Effect of a home based exercise program on the functional levels and quality of life in persons suffering from Interstitial Lung Disease (disease of the lungs)
- Conditions
- Diseases of the respiratory system,
- Registration Number
- CTRI/2020/09/027788
- Lead Sponsor
- Revati Amin
- Brief Summary
The aim of the study is to check the efficacy of home-based pulmonary rehabilitation program on functional capacity and quality of life in interstitial lung diseases in India.
Objective 1: Development and validation of a home based pulmonary rehabilitation booklet for interstitial lung disease participants.
Objective 2: To evaluate the efficacy of home based pulmonary rehabilitation on the functional capacity and Quality of Life in interstitial lung disease participants.
Supported evidences such as, L. Dowman et.al, in a systematic review in 2014, concluded that PR in patients with ILD has beneficial effects on exercise capacity, symptoms, QOL and survival compared with no PR in patients with ILD. Nishiyama O et.al in 2008, conducted a study to assess the benefit of home-based PR in patients with IPF in terms of quality of life, dyspnoea and exercise tolerance. He recruited 17 IPF patients and provided them with a combination of aerobic and resistance training once a week for 8 weeks. He concluded that, resting PFT remained stable for 8 weeks of PR, number of steps and 6 MWT (HR) significantly improved after PR. Improvement in QOL long term was not reflected. Only perceived physical limitation during exercise, SF-36 and VAS did show significant improvement. A result of a systematic review and meta analysis conducted by Li Cheng in 2018 stated that PR significantly improved exercise capacity and HRQOL in patients with IPF short term but failed to maintain the effects long term. The results of an only Indian study performed on 100 IPF patients for 8 weeks conducted in 2019 (Devani P. et.al) stated that there was statistically significant improvement in different muscle groups of UL and LL post 8 weeks. On comparison of parameters pre and post PR, significant improvement was found in CRDQ both individually and in global rating.
The present study procedure will be divided into 2 phases. The first phase focuses on the Development of an educational booklet. The second phase will be implementation of Home-based Pulmonary Rehabilitation Program.
**Phase 1:**Development of a booklet
-Assessment by personal interviews.
-Literature review
-Development of a PR booklet.
-Content validation and face validation of the booklet
This booklet development process, the review of existing literature, in depth interview feedback from participants and expert opinion will be utilized.
The educational material will be developed by literature reviewing. Interview guide development will be based on assumptions gained via
Personalized In- depth interviews taken with the ILD participants.
These interviews will be related to the knowledge, attributions, clarifications of doubt and coping mechanisms of the patient with regards to the disease, assessment techniques, exercise training, physical activity, nutrition, medications etc. This will be audio taped and transcribed using software by coding the received information.
Expert validation of the interview guide by Panel of experts including 1 pulmonology specialist, 1 physiotherapy specialist, 1 public health worker, 1 social worker, 5 target audience (i.e. people with ILD).
Interviews will be conducted until data saturation. The booklet will contain the introduction to ILD, associated signs and symptoms. Then it will be followed by the diagnostic tools used for diagnosis, the medical management along with nutritional guidance. The second half of the booklet will focus on the physiotherapy rehabilitation program. This program will be focused on the FITT principle along with assessment, evaluation followed by ongoing
maintenance and progression.
For evaluation of the booklet, content validity and appearance will be used. A protocol for trial will be designed to evaluate the content and appearance of the booklet by the experts. At the end of the evaluation, the recommendations of the experts will be condsidered.
The validation process will be conducted until no new recommendations for changes and recommendations have been saturated. For evaluation by the ILD participants, they will be asked to handle the booklet and analyse figures and texts. During the interviews, notes of comments, opinions and suggestions of the participants concerning the booklet will be recorded.
Data will be compiled and statistical analysis of agreement will be performed using the adequacy of proportions adjustments of experts who agree with the relevance of the educational booklet.
**Phase 2:**Home based pulmonary rehabilitation program
The protocol will follow the SPIRIT 2013 (Standard Protocol Items: Recommendations for interventional Trials) and the Template for Interventions Description and Replication (TIDieR) checklist for description of the interventions.
The participants fulfilling the eligibility criteria will be included in the study. The participants will be screened initially. Participant information sheet and informed consent will be obtained from the participants. Those willing to participate in the study will be then assessed for the baseline measurements.
Baseline measurements:
The patient’s demographic data, pulmonary function test values will be noted. Generic quality of life using SGRQ and Disease specific quality of life would be measured using K-BILD questionnaire. Dyspnoea will be assessed using MMRC scale. Level of fatigue at rest and on activity will be assessed using VAS. The ADL affection will be assessed using LCADL questionnaire. The endurance will be assessed using UULEX. Also the 5 sit to stand test will be done to assess the muscle strength in the lower limbs. Functional capacity will be measured using 6 minute walk test when the exacerbation is reduced for patients admitted in the hospital.
Randomization:
For the process of randomization, the following steps will be considered :
· Sequence generation: Using a computer generated random numbered tables.
· Randomization: Block randomization will be done. As per the sample size (n= 106), the participants will be divided into 26 blocks with a 4
participants in each block.
· Allocation concealment: Using equentially numbered, opaque sealed envelopes.
· Blinding: The outcome measures will be assessed by another assessor who is a Ph.D. candidate. This assessor will be blinded for the groups thus allocated to the participants.
The process of randomization would be done by a Professor who is a Ph.D. (VK)
After randomization, participants will be allocated to the study group (n= 53) and the control group (n=53).
In the interventional group the participants will be assessed and would be given a home-based pulmonary rehabilitation program consisting of 5 sessions for each patient. Each session will comprise of 10 minutes of warming up, 30 minutes of exercise training and 5 minutes of cooling down. A total of 45 minutes of exercise program will be delivered to the patients. The entire procedure will be explained to the patient in detail during the first visit. All the exercises will be physically demonstrated by the physiotherapist to the patient before beginning with the exercise program. The program consists of endurance training, resistance training, flexibility training as described in the table below. Also the participants will be given the educational booklet. The contents of the booklet will be explained in detail to the patient. The patient will be asked to take the booklet together with them at home so that they can refere to it whenever they need. The progression will be decided based on the further face to face follow ups with the patient.
In the control group, the participants will be given rehabilitation exercises as per the assessment done and no booklet will be provided. The exercise would consist of the FITT principal which will be combination of aerobic and resistance training along with breathing exercises as mentioned in the table below. They will be given general instructions and would be asked to do the same at home.
Adherence: All the study participants will be provided with log books to check for adherence.
Risk factors: Risk factors such as desaturation during the exercise program will be mitigated by monitoring the saturation on the pulse oximeter and also by grading it with respect to Rating of Perceived Exertion on the Borg scale also by allowing intervals and rest between the exercise sessions. The patients will be asked to hault the exercise if they feel it is somewhat hard on the BORG scale. The risk of injuries will also be considered for the patients. Risk of pain will be avoided by education on the use of proper warm up and cool down. Then education on application of ice packs in case to muscle soreness.
Progression: The progression of the exercise program will be decided as per the distance travelled in during the 6 MWT and as per the levels of fatigue and dyspnea during the initial exercise prescription. The patients will be asked to continue with the home-based pulmonary rehabilitation program for 3 months. Regular follow-up on the general health of the patients will be taken by regular telephonic calls. The patients will be re-assessed after 1 month and 3 months to note the improvement and to decide the progression of the exercise program.
Post assessment:
The patients will be given a telephone call every week for the entire duration of study (3 months) to ask about their general wellbeing and their health status. The patients will be asked to come for follow-up to the hospital clinic after 4 weeks. On arrival, the participants will be reassessed and will be given progression exercises as described in the table. All the above mentioned outcome measures will be assessed by the same outcome measure investigator. The participants will be sent back home.
The participants will be called telephonically every week for knowing their general well-being and their health status. The participants will return to the hospital clinic for follow-up after 3 months. On arrival, the participants will be reassessed. The patient will be assessed for all the outcome measures by the outcome measure assessor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 106
- Physician and radiologically (HRCT) diagnosed interstitial lung disease patients.
- Clinically stable and ambulant with or without assistive aids.
- Able to perform 6 MWT and maintain SPO2≥ 80% during the test.
- Supplemental oxygen users.
- Those unable to ambulate.
- Recent myocardial infarction, unstable angina, acute pulmonary oedema, acute myocarditis or pericarditis, severe rhythm disorders, non-ambulatory rheumatic diseases, severe pulmonary artery hypertension.
- Acute exacerbation of interstitial lung disease- dyspnea grade 4.
- Those unable to follow written and verbal commands.
- Musculoskeletal conditions like severe osteoarthritis, disk prolapse, recent fractures and recent joint replacement surgeries if any that prevent gentle exercises.
- Neurological and orthopedic conditions impairing mobility- stroke, spinal cord injury.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -6 minutes walk test, At baseline, after 4 weeks, after 3 months -King’s-BREF Interstitial Lung Disease (K-BILD) At baseline, after 4 weeks, after 3 months -St George Respiratory Questionnaire (SGRQ), At baseline, after 4 weeks, after 3 months
- Secondary Outcome Measures
Name Time Method -Modified Medical Research Council (MMRC), -Visual analog scale (VAS),
Trial Locations
- Locations (1)
Department of physiotherapy, Cardiopulmoanry physiotherapy lab, Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Department of physiotherapy, Cardiopulmoanry physiotherapy lab, Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaRevati AminPrincipal investigator7892252445revati.amin@learner.manipal.edu