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Effectiveness of pulmonary rehabilitation on functional exercise capacity & health related quality of life (HRQOL) among individuals with post tuberculosis lung disease: A multicentric pre & post-interventional study
For correspondence: Dr Sanjeev Sinha, Department of Medicine, All India Institute of Medical Sciences, New Delhi 110 029, India e-mail: drsanjeevsinha@gmail.com
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Received: ,
Accepted: ,
Abstract
Background & objectives
Pulmonary rehabilitation (PR) has been extensively studied and proven beneficial in various respiratory conditions such as chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD). Individuals with post-tuberculosis lung disease (P-TBLD) have limited exercise tolerance and a significant disability affecting daily living, much like those with COPD. Hence, they appear to be good candidates for PR. This study aimed to determine the effectiveness of an outpatient PR protocol on functional exercise capacity and health-related quality of life (HRQOL) in individuals with P-TBLD. Furthermore, the effectiveness of adherence to the PR protocol among the participants as well as identifying the gaps and barriers in accessing PR were also determined.
Methods
This is a multicentric pre- and post-interventional study conducted across five centres in India. 260 individuals with P-TBLD were included if they could complete more than 80 per cent of the physiotherapist’s training sessions at the time of enrollment had previously received treatment for pulmonary tuberculosis and were negative for acid fast bacilli (AFB) on sputum examination. Individuals were excluded if they had preexisting lung disease other than P-TBLD or suffered from any mental, neurological, musculoskeletal, or unstable cardiovascular disease that could impair their performance during the exercise training sessions. Pre- and post-intervention assessments included clinical symptoms, exercise intolerance, pulmonary function test (PFT), 6-minute walk test (6MWT), muscle strength testing, and St. George Respiratory Questionnaire (SGRQ) score for HRQOL. Participants received PR training at first visit in OPD and were advised to follow it at home and telephonic follow up was done for a duration of 12 wk.
Results
Out of the 260 participants who were enrolled, 246 patients completed the post-intervention evaluation following 12 wk of the PR protocol. Clinical parameters, the 6MWT, the functional balance test, and the muscle strength test all showed significant improvement after PR. Significant improvement was observed across all domains of the SGRQ score. Pulmonary function measures showed significant improvement in FEV1 and FVC parameters post intervention.
Interpretation & conclusions
This study provides compelling evidence that PR is beneficial for post-TB patient, leading to notable improvements in the exercise capacity, symptom management as well as the overall quality of life. The findings support the implementation of PR protocol on a larger scale within national health frameworks, particularly in countries with high TB prevalence. By integrating PR into the National Tuberculosis Elimination Programme, it is possible to offer a comprehensive care approach that sets standard indicators for the surveillance of P-TBLD and addresses the long-term health needs of TB survivors.
Keywords
6-minute walk test
HRQOL
pulmonary function test
pulmonary rehabilitation
tuberculosis
TB
India reported the highest number of tuberculosis (TB) cases (2.8 million) in 2022, accounting for 27 percent of the global burden1. The number of successfully treated individuals for TB has increased with 21.7 per cent of surveyed individuals in India experienced P-TBLD2,3.
It is now reported that most of the individuals treated for TB report health problems due to P-TBLD4,5. However, such individuals with post-TB lung disease are not given priority in the current healthcare systems or TB programmes. Given the high TB burden in India, the current study aimed to assess a comprehensive rehabilitation programme in patients with P-TBLD to support long term health outcomes. Although there have been studies on PR in post-TB patients, there are only a few studies from India, despite the high TB burden in India. Most published studies have assessed the utility of improving exercise capacity, but there is a need to highlight the impact on quality of life (QoL) due to P-TBLD as determined in this study6. PR is the core intervention in P-TBLD and has remained poorly accessible or utilised globally. The lack of awareness of PR benefits and a formal PR training for physiotherapists has also contributed to under-resourced allocation for the PR programme7. This study hence explored the gaps and barriers in the implementation of PR, which will help in improving accessibility to PR. For instance, the current guidelines for managing TB by the World Health Organization (WHO) define ‘treatment success’ solely in terms of microbiological outcomes and survival; measures of tuberculosis-associated morbidity are not considered following treatment8. Although TB diagnosis and treatment have saved an estimated 66 million lives over the past 20 years, there is still an underappreciated burden of ongoing morbidity for those who survive the disease, which includes both physical and psychosocial issues even after treatment is completed9. Previous systematic reviews have shown that between 15- 60 per cent of TB survivors had respiratory function impairment10,11. Thus, there is a need to evaluate every individual completing TB treatment for post-TB lung disease. According to a modelling study, P-TBLD accounts for nearly half of the global burden of TB-related mortality and morbidity12.
WHO policy acknowledges P-TBLD as a significant challenge in tuberculosis programmes since these programmes lacks follow up strategies and neglect post-treatment care13. The most common site of TB involvement is the lung, however, even after completion of the treatment radiological changes can persist. Furthermore, persistence of abnormal airway physiology and anatomical lung destruction can also appear with extensive fibrosis, bronchiectasis, collapse, etc14. The post-TB pulmonary impairment can be categorised into bronchial airway disease, lung parenchymal disease, or pleural/chest wall, vascular, and mediastinal15,16. The post-TB changes result in severe dyspnoea, exhaustion, a decrease in physical activity, multiple hospital admissions, and psychosocial isolation, increasing post-TB mortality. Therefore, rehabilitation programmes for those with post-TB sequelae should be part of the strategy, in addition to early diagnosis, prevention, and appropriate treatment for TB.
American Thoracic Society/European Respiratory Society (ATS/ERS) Statement defined Pulmonary rehabilitation (PR) in 201317, and it typically includes addressing individual goals with comprehensive patient assessment, chest physiotherapy, supervised exercise training, self-management education, psychosocial support, and nutritional counselling18-20. PR plays a crucial role in managing chronic respiratory diseases (CRDs). While the foundation of PR research was initially established for COPD, its effectiveness has now been recognised for other CRDs, such as ILD, pulmonary hypertension (PH), asthma, bronchiectasis, lung cancer, and for individuals recovering from lung transplants or SARS-CoV-2 (COVID-19) infection21-26. One major cause of CRD is P-TBLD, P-TBLD is known to be one of the major cause of CRD. In this context, pulmonary rehabilitation PR holds the potential to improve patient-related outcomes and overall health status. Thus, there is a need for public awareness for recognition of the PR protocol.
Materials & Methods
This study was a multicentric pre- and post-interventional study, conducted across five centres in India namely, All India Institute of Medical Sciences (AIIMS), New Delhi, and Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, and Government General & Chest hospital, Hyderabad and Mysore Medical College and Research Institute, Mysore and Parul Institute of Medical Sciences and Research (PIMSR), Parul Sevashram Hospital, Parul University, Vadodara, Gujarat. Ethics approval for the study was obtained from the Institutional Ethical Committee (IEC) of each of the participating institutes.
Study participants
Participants were recruited from the five chosen study centres. Participant recruitment was undertaken between March 2023 to March 2024. Individuals ≥ 18 yr of age who were previously treated for pulmonary TB and developed post-pulmonary TB changes in the form of any chronic respiratory abnormality, with or without symptoms any point after completion of their treatment and attributable to previous history of tuberculosis27. Such individuals were included if they were ‘able to perform >80 per cent of the rehabilitation training at their first visit with the physiotherapist. Those unwilling to participate, had pre-existing lung diseases other than P-TBLD, had active tuberculosis, on treatment for tuberculosis, sputum-positive pulmonary tuberculosis, or suffered from any mental, neurological, musculoskeletal, or unstable cardiovascular disease that could impair their performance during the exercise training sessions were excluded.
Study protocol
All participating individuals underwent detailed history taking, clinical examination, anthropometrical evaluation, blood pressure measurement, and detailed demographic data were collected. Under the supervision of a qualified technician, each participant used a body box plethysmograph to perform spirometry. The 6MWT was used to evaluate each participant’s tolerance for exercise, as per the American Thoracic Society’s guidelines28. The functional balance test (FBT) was evaluated by having the participant stand up and walk three meters, then turn around, walk back to the chair, and sit down. This procedure was known as the time up and go test. There were two tests run, and the best result was considered. The 10-repetition maximum (RM) and free weights test were employed by physiotherapists to evaluate the strength of the dominant limbs’ shoulder flexors and knee extensors in both the upper and lower limbs (Supplementary material 1). SGRQ was administered to each participant under supervision by the investigator to determine HRQOL (Supplementary material 2). In the PR protocol, exercise training session was conducted for all participants which included a warm up and cool down period including a range of motions including stretching, endurance and strength training, breathing exercises, respiratory muscle exercises with incentive spirometer and airway clearance techniques with postural drainage were done with most effective position marked at the initial sessions with the physiotherapist. The core components of the PR protocol are summarised in table I. Advice regarding nutrition and diet was given by the nutritionist. An educational interactive session focusing on causes, manifestations, and management was conducted. Behavioural and psychosocial intervention was provided in the form of an interactive discussion with the participants and their family members. A video based on this PR protocol was shared with the patients and advised to do the above exercises daily. Adherence was ensured by telecommunication thrice a week for 12 wk. Participants were instructed to complete at least three exercise sessions a week. Those who completed less than 70 per cent sessions of the PR protocol or did not follow up after 12 wk of the same were categorised as ‘nonadherence’. To identify the gaps and barriers in the PR protocol, a structured questionnaire was administered to health care professionals to gather data on their knowledge and practices related to PR for P-TBLD. The questionnaire covered several domains, including personal resources, logistics, and institutional facilities. A total of 45 healthcare professionals participated in the survey. The questionnaire highlights several critical gaps and barriers in the current provision of PR for post-TB participants (Supplementary material 3). At the end of 12 wk of intervention, participants were evaluated for any changes in clinical parameters, dyspnoea score, muscle strength, FBT, exercise tolerance, and SGRQ score. Data on lung function, dyspnoea, muscle strength, exercise tolerance, and HRQOL were collected before and after the PR protocol.
| S. no. | Components | Significance | Intervention | Follow up |
|---|---|---|---|---|
| 1 | Aerobic exercises |
Endurance training, Improves exercise capacity |
Endurance training (walking/cycling) was done at 60-80% of the average speed achieved during the 6MWT. 30 min 3-5 times/wk The training intensity was adjusted according to the patient’s symptoms on the modified Borg scale (a rating of 4-6 on perceived dyspnoea/fatigue will be an indicator of adequate training intensity). |
Thrice a week, telephonically. |
| 2 | Muscle exercises | Strength training (Helps improve muscle mass and bone mineral density.) | Training was done with resistive loads with repetitions, initial loads equivalent to either 60 % of the one repetition maximum (i.e., the maximal load that can be moved only once over the full range of motion without compensatory movements) or one that evokes fatigue after 10-RM. Participants were asked to perform 1 of 10 repetitions of each exercise at a workload of 60% of the one repetition maximum (1 RM). | The exercise dosage was increased when an individual could perform the current workload for 1 or 2 repetitions over the desired number of 6 to 12, on 2 consecutive training sessions |
| 3 | Breathing exercises | Functional lung capacity | Breathing exercises were advised with diaphragmatic breathing and pursed lip breathing for 10 min every day; respiratory muscle exercises were demonstrated with inhaling maximally through incentive spirometer. | Ensured three times a week telephonically |
| 4 | Airway clearance techniques | Postural drainage to help reduce sputum quantity, better ventilation and relief of symptoms | The most effective position was marked at first sessions with the physical therapist. Done before a meal, once or several times a day, but not more than 20-30 min, during which time several positions would be used, 5-10 min each. At the end of each position period, the drained region would be tapped for 1 min. | Ensured thrice a week telephonically |
| 5 | Nutritional support | Most of post-TB patients are cachexic and malnourished, so providing better nutrition in the form of high protein diet, high calorie intake could improve their baseline quality of life |
The patient counselling was done along with family member/care giver. Nutritional assessment. Any co-morbidity/special medical need. Tailored treatment from foods and medical supplements. |
At first visit and ensured thrice a week telephonically |
| 6 |
Psychological support |
To reduce social isolation, depression and anxiety. |
Psychological assessment; psychological support and to consider a self-help group |
At first visit and ensured thrice a week telephonically |
| 7 | Self-management education | To encourage self- management, disease education, behaviours to improve overall health |
Educate about smoking cessation, importance of compliance to pharmacotherapy, assist with early identification and treatment of acute exacerbations. Educate about how to manage acute dyspnoea, improve body composition, promote mental health. |
At first visit and ensured thrice a week telephonically |
This table shows the significance of the core variables of the PR programme and a detailed description on how to perform these. The standard of follow up was set for all the variables as mentioned in the table.
Statistical analysis
This study was powered on the primary outcome. Power was set at 0.8 and alpha at 0.05. It was determined that a 0.1±0.5 absolute decrease in the mean FEV1 in the intervention group compared to the pre-intervention group would be meaningful, based on the best scenario found in Swain et al29, 2019. The calculated sample size was 200. Considering the loss to follow up at 15 per cent, it was determined that 235 participants would be needed for the study. We therefore recruited 271 study participants.
The primary and safety analysis set for all parameters consisted of all enrolled patients who had a baseline value. Subject compliance with the protocol was found to be nearly 95%. The patient-reported outcome (PRO) analysis set consisted of all enrolled patients who completed both the baseline and endline visits. Data for all primary and secondary outcomes, either because of a missed visit end line was imputed using the last-value-carried-forward (LVCF) approach. In the available data approach, missing values were not imputed (per protocol analysis in Supplementary material 4). Data was recorded on predesigned case report forms and managed on Excel spreadsheets. Quantitative variables were summarised as mean–standard deviation or median (range) as per their distribution (normal/non-normal). A paired t-test/Wilcoxon signed rank test was used to compare normal/non-normal pre and post intervention values, respectively. STATA 11.0. Statistical software was used for data analysis. A P value of less than 0.05 was considered statistically significant.
Results
Out of 329, 58 participants were excluded as per the exclusion criteria. 11 participants could not perform PFT during assessment at baseline. The remaining 260 patients were enrolled in the intervention protocol (Fig. 1). Of these, four dropped out of the study, and 10 were lost to follow up. Hence total of 246 participants finished the post-intervention evaluation.
- Flow Diagram of the study design. CBC, Complete blood count; LFT, Liver function test; KFT, kidney function text; HRCT, high-resolution computed tomography; CECT, contrast enhanced computed tomography; HRQOL, health-related quality of life.
Demographic and clinical profile
A total of 260 participants were included in the study of whom 246 participants completed the PR protocol and followed up after 12 wk. Study showed a preponderance of male population (67% in males & 33% in females) with comparable mean age (48.53 vs. 48.54; P=0.99). Most participants in both groups did not smoke, and no discernible differences were found in baseline clinical profile or demographics (Table II).
| Demographic parameters | Pre-intervention participants (n=260) | Post intervention participants (n=246) | P value | |
|---|---|---|---|---|
| Age in yr (Mean±SD) | 48.53±15.33 | 48.54±15.5 | 0.992 | |
| Gender, n (%) | Male | 175 (67) | 163 (66) | 0.017 |
| Female | 87 (33) | 83 (34) | ||
| Education, n (%) | Illiterate | 102 (39) | 97 (39) | 0.982 |
| Primary school | 102 (39) | 98 (40) | ||
| Secondary school | 37 (15) | 33 (14) | ||
| College and above | 19 (7) | 18 (7) | ||
| Employment, n (%) | Unemployed | 107 (42) | 102 (42) | 0.955 |
| Daily wage | 117 (45) | 108 (44) | ||
| Regular employed | 36 (13) | 36 (14) | ||
| Smoker, n (%) | No | 229 (88) | 217 (88) | 0.505 |
| Yes | 31 (12) | 29 (12) | ||
| Duration post pulmonary TB in yr (mean±SD) | 7.64±3.68 | 10.84±11.43 | 0.613 | |
| Duration of ATTin months (mean±SD) | 10.72±10.96 | 7.83±3.88 | 0.677 | |
| Weight loss, n (%) | No | 214 (83) | 202 (82) | 0.965 |
| Yes | 46 (17) | 44 (18) | ||
| Loss of appetite, n (%) | No | 199 (77) | 190 (77) | 0.958 |
| Yes | 61 (23) | 56 (23) | ||
| Fever, n (%) | No | 223 (85) | 210 (86) | 1.000 |
| Yes | 37 (15) | 35 (14) | ||
| Cough, n (%) | No | 45 (17) | 41 (16) | 0.993 |
| Yes | 215 (83) | 205 (84) | ||
| Chest pain, n (%) | No | 200 (77) | 188 (77) | 0.535 |
| Yes | 60 (23) | 58 (23) | ||
| Haemoptysis, n (%) | No | 239 (92) | 225 (91) | 0.553 |
| Yes | 21 (8) | 21 (9) |
This table shows demographic characteristics of participant population enrolled (n=260) at baseline and participants who completed the PR protocol (n=246). SD, standard deviation
Clinical profile and clinical status
The most frequent presenting symptom was cough, followed by dyspnoea. It was observed that after intervention, number of participants in MMRC grade 3 decreased significantly (P<0.001) (Fig. 2). A significant reduction in symptoms such as cough, fever, chest pain, loss of weight, and loss of appetite was observed after 12 wk of the implementation of PR protocol (Table III).
- Graph showing MMRC grade. Shows the (A) pre and (B) post intervention change in MMRC grade with significant increase in number of patients in MMRC Grade 0 and 1 and decrease in number of patients in Grade 2 and 3.
| Observations | Pre intervention (n=260) | Post intervention (n=260) | P value | ||
|---|---|---|---|---|---|
| No, n (%) | Yes, n (%) | No, n (%) | Yes, n (%) | ||
| Smoking | 229 (88) | 31 (12) | 235 (90) | 25 (10) | 0.01 |
| Weight loss | 214 (82) | 46 (18) | 255 (98) | 5 (2) | <0.001 |
| Loss of appetite | 199 (77) | 61 (23) | 246 (95) | 14 (5) | <0.001 |
| Cough | 45 (17) | 215 (83) | 149 (57) | 111 (43) | <0.0001 |
| Chest pain | 200 (77) | 59 (22) | 233 (90) | 27 (10) | <0.001 |
| Fever | 223 (85) | 37 (14) | 246 (95) | 14 (5) | 0.0001 |
| MMRC (0) | 102 (39) | 118 (46) | <0.001 | ||
| MMRC (1) | 35 (13) | 53 (20.5) | |||
| MMRC (2) | 90 (35) | 71 (27) | |||
| MMRC (3) | 33 (13) | 16 (6) | |||
| MMRC (4) | 0 | 1 (0.5) | |||
MMRC, modified medical research council
Primary outcome
At baseline mean 6MWT was 364.11 m, the mean muscle strength was 1.5 kg for the upper limb and mean FBT was 9.99 sec and the median of PFT parameters Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), and FEV1/FVC at baseline was 1.16 L, 2.04 L, 66.3 per cent, respectively. 6MWT (P<0.001), FBT (P<0.001), and muscle strength (P<0.001) all showed significant changes following 12 wk of PR (Fig. 3). The FEV1 and FVC parameter showed a significant improvement (p-value <0.001), but FEV1/FVC did not show a significant improvement as shown in table IV. PFT patterns observed in patients were 38 per cent normal, 20 per cent obstructive, 85 per cent restrictive, and 71 per cent mixed.
- Graph showing effect of PR on functional exercise capacity post intervention. Shows significant improvement in 6MWT, FBT and muscle strength (P<0.001).
| Observations | Pre (n=260) | Post (n=260) | Mean difference (95%CI) | P value |
|---|---|---|---|---|
| FEV1 Median (Min-Max) | 1.16 (0-3.81) | 1.38 (0.44-4.03) | - | <0.001 |
| FVC Median (Min-Max) | 2.04 (0-4.3) | 2.38 (1-49) | - | <0.001 |
| FEV1/FVC Median (Min-Max) | 66.3 (0-100) | 79 (0.24-100) | - | 0.59 |
| Muscle strength KG (Mean±SD) | 1.5±0.47 | 1.71±0.52 | 0.21 (0.15-0.27) | <0.001 |
| 6 MWT Meters (Mean±SD) | 364.11±146.1 | 395.07±157.7 | 31.3 (37.2-25.39 | <0.001 |
| FBT Seconds (Mean±SD) | 9.99±3.39 | 8.42±3.02 | 1.57 (1.25-1.88) | <0.001 |
| SGRQ symptom Median (Min-Max) | 58.6 (0-389.8) | 30.95 (0-112.8) | - | <0.001 |
| SGRQ Impact Median (Min-Max) | 52.9 (0-457) | 31.1 (0-456) | - | <0.001 |
| SGRQ Activity Median (Min-Max) | 59.5 (0-522.8) | 34.66 (0-701) | - | <0.001 |
FEV1, forced expiratory volume in the first second; FVC, forced vital capacity; 6MWT, 6-minute walk test; FBT, functional balance test; SGRQ, St. George respiratory questionnaire; SD, standard deviation; CI, confidence interval
Secondary outcome
It was observed that the difference between all the components of the SGRQ score, i.e., symptom, impact, and activity components after 12 wk of intervention was significant (P<0.001) (Fig. 4). Adherence to the PR protocol was 71.7 per cent during the study and it was observed that there were no significant differences in primary outcomes as shown in table V while FEV1 shows significant improvement in participants who were adherent. As per the HCP survey, it was observed that the healthcare professionals were aware of the P-TBLD but were not aware of standard guidelines and did not follow any structured guidelines for PR. There are facilities, trained physiotherapists, and equipment for PR, but a lack of standard protocol for referral of P-TBLD. As per the survey, access to telecommunication in many setups is lacking, while HCPs are willing to provide tele-PR. As per the survey, the referral rate of patients was 39 per cent, with less than 40 per cent of them completing the PR protocol (Supplementary material 5). While most of the dropouts were due to difficulty in follow up or the unwillingness of the study participants, most of them (⁓89%) believed earlier PR would have made them better, and as per the survey, it was observed that 97 per cent of participants were likely to continue to perform PR even after the study.
- Graphs showing effect of PR on HRQOL post intervention. Shows significant improvement in all components of SGRQ score (P < 0.001).
| Observations | Pre intervention | Post intervention | ||||||
|---|---|---|---|---|---|---|---|---|
| Adherent (n=210) | NOT adherent (n=50) | Mean difference (95% CI) | P value | Adherent (n=210) | NOT adherent (n=50) | Mean difference (95% CI) | P value | |
| FEV1 (L) Median (Min-Max) | 1.83 (0-3.81) | 1.14 (0-3.5) | 0.23 | 2.1 (0.4-4.0) | 1.1 (0.46-3.3) | 0.02 | ||
| FVC (L) Median (Min-Max) | 2.37 (0-4.3) | 1.8 (0-4.3) | 0.42 | 2.76 (0.5-4.9) | 1.88 (0.85-4.21) | 0.07 | ||
| FEV1/FVC (%) Median (Min-Max) | 80.7 (0-100) | 73 (0-98) | 0.01 | 79.1 (24-100) | 65.6 (0.75-98) | 0.78 | ||
| Muscle strength (KG) (Mean±SD) | 1.52±0.79 | 1.93±0.63 | 0.08 (0.15-0.32) | 0.46 | 1.73±0.86 | 1.61±0.75 | 0.12 (0.13-0.38) | 0.34 |
| 6MWT (m) (Mean±SD) | 368.9±1.48 | 343.9±135.9 | 24.9 (20.2-70.1) | 0.27 | 404.3±159.3 | 357.9±146.3 | 46.4 (2.16-95.1) | 0.06 |
| FBT (sec.) (Mean±SD) | 10.1±3.3 | 9.4±3.5 | 0.63 (0.41-1.6) | 0.23 | 8.39±2.82 | 8.51±3.8 | 0.11 (0.82-1.05) | 0.81 |
This table shows association between FEV1, FVC, FEV1/FVC, Muscle Strength test, 6MWT and FBT with Adherence
Discussion
The idea of PR in chronic lung disease is not new, but there are only a few studies on its benefits in chronic lung impairment from previously treated tuberculosis. Individuals with P-TBLD appear to be good candidates for PR because, like patients with COPD, they have a significant disability and limited exercise capacity that affects daily living30. In our research, functional exercise capacity was monitored by 6MWT, muscle strength testing, and functional balance up and go test not yet explored previously in many studies and it was found that all three tests showed significant improvement after PR for 12 wk. Few studies have demonstrated significant improvement in 6MWT and exercise capacity after 8-12 wk of PR31,32. Due to physical inactivity and systemic inflammation, individuals post-TB are prone to develop musculoskeletal dysfunction. In the United States in 1997, guidelines for exercise training for patients with COPD were announced33. In contrast, there are no standard guidelines formulated for patients with P-TBLD. These patients enter a vicious cycle of fatigue, dyspnoea, and falling body weight and thus develop exercise intolerance and progressive morbidity. The PR programme stops this vicious cycle and increases the patient’s capacity for exercise34.
We observed improvement in spirometry measures such as FEV1 and FVC parameters after 12 wk of intervention. Similar findings were observed in a study by Mbatchou Ngahane et al35. Variable patterns and severity of pulmonary functions are seen (obstructive, restrictive, and mixed). In our study, more than 50 per cent of patients had restrictive and mixed patterns of impaired pulmonary function. In the same way, over half of the patients in one study36 had impaired lung function, and 44 per cent of them had restrictive impairment.
Patients’ QoL is significantly impacted by pulmonary tuberculosis, both mentally and physically. Research by Guo et al37 concluded that patients, even after getting completely cured, have substantial functional impairment affecting their QoL. HRQOL was determined by SGRQ score pre- and post-intervention in our study; it was observed that all the domains of the SGRQ score, i.e., symptoms, impact, activity, and total SGRQ score, showed significant improvement. There have not been many studies on the QoL of patients post-treatment of pulmonary tuberculosis. This study was undertaken to provide a comprehensive rehabilitation protocol, inclusive of psychological and social well-being, to improve QoL after 12 wks of PR. In many studies, the improvement in exercise capacity after PR was significant, while the SGRQ score did not show significant improvement after PR38,39. Though there was a significant improvement in functional exercise capacity, HRQOL, FEV1, and FVC but the effectiveness of PR needs to be correlated with the disease severity or time since tuberculosis treatment, and duration of their active TB disease, or duration of symptoms post TB.
Only a few patients have access to PR services, and there is a need to expand these services. The American Thoracic Society (ATS) Statement 201540 addresses significant obstacles to PR, including referral, uptake, and ignorance of HCPs. Similar to the present study, it was observed in various other studies that clinicians did not know the recommendations for PR in chronic lung disease, and thus referral rates were poor41,42. Other important barriers noted in the present study were the lack of structured guidelines for referral for PR, and the less number of participants attending the protocol. Participants did not attend the PR protocol largely due to unwillingness and difficulty in accessing the facility. Similar environmental factors, such as public transport, travel distance, and weather conditions attributed to the barriers43. It was observed that the average adherence rate in this study of all the individuals enrolled was 71.7 per cent, which could be attributed to home-based PR, which was implemented by sharing videos, and to the telerehabilitation, which was ensured three times a week. Optimising the accessibility of telecommunication services can be a promising approach. The caregiver burden and accessibility are the advantages of telerehabilitation at home. Telerehabilitation offers the flexibility of being accessed anytime and from any location, thereby improving accessibility for individuals living in remote or non-metropolitan areas. This approach allows supervised exercise training to be delivered in settings where specialized pulmonary rehabilitation services are typically not available. A recently published review on telerehabilitation reported a higher completion rate of PR than in-person intervention44.
The rehabilitation protocol we conducted was observed to be a safe and effective modality for the improvement of functional exercise capacity, HRQOL in P-TBLD. The identification of P-TBLD may therefore be an important strategy to limit tuberculosis morbidity.
Overall, improvements in clinical symptoms, exercise tolerance, and functional capacity seen in this study are not only measurable but also clinically significant, enhancing the HRQoL of participants. The observed benefits motivated participants to adhere to the rehabilitation protocol. These positive outcomes pave the way for future research to assess and manage P-TBLD with a focus on optimising rehabilitation protocols to maximise effectiveness. This study provides a strong foundation for the implementation of PR in post-TB care. Future research should aim to expand on these findings, optimising protocols, and ensuring that PR becomes an integral part of TB management programmes worldwide.
Acknowledgment
Authors acknowledge the assistance provided by Dr Shivam Pandey, Dr. Binit, Mr. Aravind K, Didhiti Desai, Bhanumathy Mohanakrishnan, and other employees of the dietary and physiotherapy departments, the medicine outpatient department, the chest clinic, and the pulmonary function test room during patient enrolment, intervention, and follow up.
Financial support & sponsorship
The study received funding support from the Indian Council of Medical Research(ICMR), New Delhi (Grant Number: 5/8/5/31/ITRC-Imp/2022/ECD-1).
Conflicts of Interest
None.
Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation
The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.
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