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

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.