| CTRI Number |
CTRI/2024/10/075927 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Online and At-Home Exercise Programs for Improving Daily Activity, and Well-Being in People with Chronic Lung Disease (TELHOME-ILD): A Randomized Clinical Trial" |
|
Scientific Title of Study
|
The Effect of Telerehabilitation vs. Home-Based Pulmonary Rehabilitation on functional capacity and quality of life in patients with Interstitial Lung Disease (TELHOME-ILD): A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naga Padmaja K S |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health
Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal.
Udupi KARNATAKA 576104 India |
| Phone |
7019468774 |
| Fax |
|
| Email |
naga.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9353039762 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal
KARNATAKA 576104 India |
| Phone |
9353039762 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Naga Padmaja K S |
| Address |
Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Naga Padmaja K S |
Kasturba Hospital, Manipal |
Kasturba Medical
College, Manipal
Academy of Higher
Education, Madhav
Nagar, Manipal
Udupi Udupi KARNATAKA |
7019468774
naga.mchpmpl2023@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home based pulmonary rehabilitation program |
Participants will be screened and would be provided with home based rehabilitation program. participants will be provided with a pulmonary rehabilitation educational booklet. Participants would be recommended to perform their exercises 4-5 days per week. Participants and caregivers will track their exercise sessions in a logbook in the educational booklet. participants would be receiving weekly telephone motivational calls. |
| Intervention |
Telerehabilitation |
Participants will be screened and will be engaged in telerehabilitation program at home. During the first three months of telerehabilitation, supervised sessions of 30–45-minute sessions with warm-up and cooldown will be held 3 times per week via an online platform along with caregivers for assistance. Participants will be instructed to continue doing the exercises on the other days of the week using the developed exercise videos. After 3 months, participants will be advised to continue their exercises unsupervised using exercise videos. Participants will track their exercise sessions in a logbook during unsupervised sessions. Weekly telephonic calls would be given to track their status and check adherence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
 Clinically diagnosed ILD individuals HRCT and pulmonologists diagnosed individuals with ILD  Clinically stable individuals  Participants who can walk independently with or without assistive devices  Participants having at least 1 smartphone in the family  Participants who can maintain oxygen saturation of 80% or higher in room air during a six-minute walk test (6MWT)  Participants on intermittent oxygen therapy |
|
| ExclusionCriteria |
| Details |
 Participants with significant vision or hearing impairments  Grade 4 dyspnea on the mMRC (Modified Medical Research Council)  Inability to walk without supervision  Participants on continuous oxygen support  Recent MI, unstable angina, acute pulmonary edema, myocarditis, arrhythmias, rheumatic diseases and severe pulmonary artery hypertension (PAH). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-6 minutes walk test
-King’s-BREF Interstitial Lung Disease (K-BILD)
- European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
|
Baseline, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Modified Medical Research Council (mMRC) Dyspnea scale
- Dyspnoea-12 questionnaire
- Fatigue Severity Scale (FSS)
- London Chest Activity of Daily Living (LCADL)
- Six-minute Pegboard ring test (6PBRT)
- 30seconds Sit To Stand
- Hand grip dynamometer
- Digital hand-held dynamometer
- Depression Anxiety Stress scale (DASS-21)
- Global Physical Activity Questionnaire (GPAQ)
- Exercise Barrier/Benefits scale
- European Health Literacy Survey Questionnaire (HLS-EU-Q47)
- Pittsburgh Sleep Quality Index (PSQI)
- PROMIS questionnaire
|
All outcome measures are assessed at baseline, 1 months, 3 months, 6 months except European Health Literacy Survey Questionnaire (HLS-EU-Q47) and Exercise Barrier/Benefits scale will be assessed once.
|
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to assess the effectiveness of telerehabilitation versus home-based pulmonary rehabilitation on functional capacity and quality of life among individuals with ILD. Objective 1: To develop and validate an educational video for individuals with ILD. Objective 2: To compare the effectiveness of telerehabilitation using exercise videos and home-based using an exercise educational booklet on functional capacity and quality of life among individuals with ILD. Objective 3: To explore the experience of TR and home-based PR among individuals with ILD.
Studies have demonstrated that home-based PR using minimal resources along with an exercise education booklet brings about improvement in functional capacity and quality of life. Home-based PR is therefore established as a safe, feasible and viable alternative to center-based programs globally and nationally. TR programs have shown improvements in functional capacity and QoL among individuals with ILD globally. Additionally, virtual exercise programs are feasible, safe and acceptable among individuals with ILD. Integrating videoconferencing with educational videos could improve the outcomes among individuals with respiratory diseases.
This study has three objectives. The first objective is to develop and validate an educational video for individuals with ILD.
using comprehensive literature review and validated ILD educational booklet video will be developed. After the development of video, content validation will be done by six experts. Feedback from one round will be gathered, assessed and incorporated into the subsequent round to capture insights from the experts. PEMAT-A/V guidelines will be used to validate the video based on the following components “understandability" and "actionability" of patient education materials. Validation will also be done by the target population (ILD). For second objective, Participants will be recruited according to the eligibility criteria. Informed consent from the participants will be taken from eligible participants and a participant information sheet will be provided.
After consenting to the study, all the participants will undergo baseline assessments (demographic details, primary and secondary outcome measures).
Baseline assessments: Demographic details, Six-minute walk test (6MWT), European quality of life (EQ-5D-5L), King’s Brief Interstitial Lung Disease (KBILD), Modified Medical Research Council (mMRC) scale, Dyspnoea-12 (D-12 questionnaire), hand-held dynamometer, hand grip dynamometer, Fatigue Severity Scale (FSS), London Chest Activity of Daily Living (LCADL), six-minute peg board ring test (6PBRT), 30 Sit-to-stand (30 STS), Depression, Anxiety and Stress scale (DASS-21), Health Literacy Survey Questionnaire (HLS-EU-Q47), Pittsburgh Sleep Quality Index (PSQI), Global Physical Activity Questionnaire (GPAQ), Exercise Benefits/Barriers Scale (EBBS), PROMIS scale.
Randomization: After baseline assessments, the participants will undergo a randomization process using computer-generated random number tables. The randomization process will include block randomization and the participants will be separated into 12 boxes of six participants each. Allocation concealment will be done using sequentially numbered, opaque sealed envelopes. Participants will be allocated into either intervention group 1 or intervention group 2. 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= 36) and the control group (n=36). In intervention group 2, participants will receive home-based pulmonary rehabilitation using a developed and validated educational exercise booklet.
Intervention group 1: In intervention group 1, participants will receive a 12-week exercise program at home through telerehabilitation. During the hospital visit participants in both groups will be receiving one familiarization session. During the first three months of telerehabilitation, supervised sessions of 30–45-minute/ session along with warm-up and cooldown will be held 2 times per week through an online platform (Zoom/ Teams) along with caregivers for assistance. Participants will be instructed to continue doing the exercises on the other days of the week using the developed exercise video. After 3 months, there will be no progression of exercises. Participants will be instructed to continue their exercises unsupervised using exercise video. The exercises included are aerobic exercises, resistance training and flexibility training. Participants will track their exercise sessions in a logbook during the unsupervised period.
Intervention group 2: The exercise intensity will be individualized according to the patient’s condition. Participants will track their exercise sessions in a logbook during the unsupervised period. Participants in intervention group 2 will be receiving a home-based program through a validated educational booklet and will be asked to perform these exercises at home. This booklet consists of deep breathing exercises, resistance, flexibility, and endurance training. Participants are recommended to perform their exercises 4-5 days per week. Intervention group 2 will receive the same exercise intervention as group 1. Throughout the exercise session phase, participants in both groups will receive weekly motivational calls. The intervention is considered complete if the participant completes at least 50 out of 60 sessions within three months.
Throughout the exercise session phase, participants in both groups will receive weekly motivational calls.
Risk factors: The possible risks in this study are increase in symptoms (breathlessness and fatigue) while doing exercises, muscle soreness and pain. The mitigation strategies will be taught to the participants on managing breathlessness and fatigue by doing relaxation and breathing exercises and giving adequate rest. In case of muscle soreness and pain they will be instructed to do cryotherapy.
Participants will be receiving education on safety precautions, choose appropriate exercise attire, footwear, ventilated and non-slippery environment and also to perform warm-up and cool-down exercises. They will be asked to show the oxygen saturation using pulse oximeter on the screen during video conference sessions. During unsupervised sessions, they will be advised to monitor the saturation while doing exercises.
Follow-up assessments will be done for 1 month, 3 months and 6 months when they come to the hospital for both groups. During follow-up sessions individuals will be assessed for both primary and secondary outcome measures.
The objective 3, a qualitative study using semi-structured interviews will be conducted to explore the effectiveness of TR and home-based PR will be conducted post-therapy session. Individuals with ILD already recruited and completed the TR program or home-based PR program, of both genders and individuals speaking English and Kannada languages will be included. We aim to recruit 12 participants in each group and use the principles of data saturation to determine the qualitative sample. An interview guide will be developed. Several probes corresponding to each interview question will be used to gain more information regarding the effectiveness of the given intervention (either TR or home-based PR) to each participant. All interviews will be conducted face-to face in Kannada or English based on the participant’s convenience for 60-120 minutes. Interviews will be taken in a quite room without interruption. All the interview sessions will be audio-recorded using mobile software. The recorded interviews will be later transcribed verbatim. Themes and sub-themes will be identified from the transcribed interview scripts using thematic analysis. |