Exercise Programs for COPD

(CLD Trial)

Overseen By Jane Baldwin, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Stroke, Parkinson's, Multiple sclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different exercise programs can improve well-being in people with Chronic Lung Disease after completing regular rehab. It compares an 8-week clinic-based program (Onsite Maintenance Exercise Training) with a similar program conducted via video calls (Telehealth Maintenance Exercise) and against no additional exercises. The focus is on enhancing breathing, exercise capacity, daily activities, and quality of life. Individuals who have recently completed a rehab program and can walk independently might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore new methods for maintaining health and well-being post-rehab.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise programs are safe for adults with Chronic Lung Disease?

Research has shown that exercise programs, like those under testing, are generally safe for individuals with long-term lung conditions. Exercise sessions conducted at the facility have boosted physical abilities and improved quality of life in previous studies. These exercises are manageable for most people, typically not causing serious side effects.

Similarly, exercise programs delivered through telehealth offer a safe and effective way for patients to continue recovery at home. Studies indicate that they can improve access to care and help maintain health without major risks. Both onsite and telehealth methods aim to safely increase physical activity for those with chronic lung disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for COPD because they explore new ways to make pulmonary rehabilitation more accessible and effective. Traditional COPD treatments often require patients to travel to clinics for supervised exercise sessions, which can be challenging for many. The onsite program offers a structured, supervised environment to ensure patients get the full benefit of rehabilitation. Meanwhile, the telehealth program uses Zoom to deliver the same quality of care remotely, breaking down barriers like distance and mobility issues. These innovative approaches aim to improve patient engagement and outcomes by making rehabilitation more convenient and personalized.

What evidence suggests that this trial's exercise programs could be effective for Chronic Lung Disease?

Research has shown that exercise programs, whether in person or through telehealth, can benefit people with Chronic Lung Disease. This trial will compare two such programs: Onsite Pulmonary Rehab and Telehealth Pulmonary Rehab. Studies have found that pulmonary rehabilitation via telehealth can improve quality of life and exercise ability for people with COPD, making it as effective as traditional in-person programs. In-person exercise boosts endurance and aids recovery over time. Telehealth programs increase accessibility to these benefits. Overall, both in-person and telehealth exercise programs are promising options for managing symptoms and improving life quality in patients with Chronic Lung Disease. ^{1 5 6 7 8}

Who Is on the Research Team?

Shweta Gore, PhD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

This trial is for adults with COPD who have completed traditional exercise or physical therapy. They must be able to participate in an 8-week supervised maintenance exercise program either onsite or through telehealth. There's no detailed exclusion criteria provided, but typically those unable to perform exercises or follow the protocol may not qualify.

Inclusion Criteria

Have ability to connect to the internet

I can walk for six minutes with or without extra oxygen, keeping my oxygen levels above 85%.

Able to follow commands and instructions in the English language

Exclusion Criteria

I mainly use a wheelchair to get around.

I cannot communicate in English.

I have a condition like Parkinson's or severe arthritis that makes it hard for me to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a baseline assessment at the IMPACT Practice Center at MGH Institute of Health Professions

1 day

1 visit (in-person)

Treatment

Participants receive an 8-week supervised exercise intervention either onsite or via tele-rehab

8 weeks

8 visits (weekly, in-person or virtual)

Follow-up

Participants are monitored for clinical outcomes at 4 months post-intervention

4 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Onsite Maintenance Exercise Training
• Telehealth Maintenance Exercise

Trial Overview The study aims to compare two types of maintenance exercise programs for COPD patients: one conducted onsite and the other via telehealth, against a control group receiving biweekly check-ins without active intervention. The focus is on measuring breathlessness, exercise capacity, physical function, activity levels, and quality of life.

How Is the Trial Designed?

Group I: Telehealth Pulmonary Rehab Experimental Treatment 1 Intervention

Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided remotely using Zoom videoconferencing technology.

Group II: Onsite Pulmonary Rehab Experimental Treatment 1 Intervention

Supervised pulmonary rehabilitation including exercise training, activity counselling, and education provided onsite.

Group III: Control Active Control 1 Intervention

Control group participants will only be seen during the outcomes assessments at the MGH Institute of Health Professions at times 0, 1, and 2, but will receive no active supervised intervention. Control group participants will go home with discharge instructions to maintain a home exercise routine provided to them at discharge. Bi-weekly check in phone calls from the study team will continue to ensure participant engagement in the study. During the phone calls, participants will be encouraged to keep a log of their weekly activities in a journal.

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

Published Research Related to This Trial

A rehabilitation manual helped patients with COPD maintain their exercise capacity and quality of life after completing a 12-week out-patient pulmonary rehabilitation program, while those without the manual experienced a decline in their improvements.

After 12 weeks at home, the manual group showed no significant changes in their 6-minute walk test and step test results, whereas the control group lost ground, indicating that the manual was effective in preserving rehabilitation benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Home-Based Manual as Part of a Pulmonary Rehabilitation Program. de Souza, Y., da Silva, KM., Condesso, D., et al.[2019]

Home-based exercise therapy using advanced telehealth technology (ATT-ET) significantly improves exercise capacity, quality of life, and functional dyspnoea in people with chronic obstructive pulmonary disease (COPD) compared to no exercise therapy, based on a systematic review of 15 trials with 1,522 participants.

ATT-ET shows similar or better effects on quality of life and functional dyspnoea compared to both in/outpatient exercise therapy and home-based exercise therapy without telehealth, indicating its effectiveness as a viable alternative for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced telehealth technology improves home-based exercise therapy for people with stable chronic obstructive pulmonary disease: a systematic review. Bonnevie, T., Smondack, P., Elkins, M., et al.[2022]

In a 2-year international trial with 120 COPD patients, both telerehabilitation and unsupervised treadmill training significantly reduced hospitalizations and emergency department visits compared to standard care.

Participants in the telerehabilitation and unsupervised training groups not only had better health status for a year but also achieved and maintained significant improvements in exercise capacity, highlighting the effectiveness of these home-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Telerehabilitation or Unsupervised Training at Home for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Zanaboni, P., Dinesen, B., Hoaas, H., et al.[2023]

A 12-week rehabilitation program for COPD patients that includes both ventilatory and nonventilatory muscle exercises can significantly improve their physical capabilities, utilizing whole-body exercises and inspiratory resistive loading.

The program is tailored to each patient based on their maximum breathing capacity and can be effectively implemented in community hospitals, making it accessible for most COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilatory and nonventilatory muscle exercise in COPD rehabilitation. Zack, MB., Palange, AV., Drews, PG., et al.[2008]

A study involving 22 participants, including 14 healthcare professionals and 8 patients with COPD, showed a positive willingness to adopt a remote pulmonary rehabilitation (PR) solution, highlighting its potential to reduce hospital visits and enhance self-management.

The findings suggest that effective telehealth technologies for COPD should combine remote and in-person elements, provide training, and ensure a user-friendly interface to meet the needs of both patients and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual validation of an innovative remote pulmonary rehabilitation solution for Chronic Obstructive Pulmonary Disease. Méndez, A., Labra, P., Guerrero, JP., et al.[2022]

The study successfully implemented a province-wide tele-pulmonary rehabilitation (tele-PR) program for individuals with COPD, demonstrating high accessibility and feasibility with over 70% program completion and no major adverse events reported.

Both tele-PR and standard PR showed significant improvements in physical performance and quality of life, with tele-PR participants maintaining better long-term improvements in quality of life scores compared to those in standard PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accessibility, Feasibility, and Safety of a Standardized Community-based Tele-Pulmonary Rehab Program for Chronic Obstructive Pulmonary Disease: A 3-Year Real-World Prospective Study. Alwakeel, AJ., Sicondolfo, A., Robitaille, C., et al.[2022]

A pilot study involving 10 COPD patients showed that a long-term telerehabilitation program, including home exercise training and telemonitoring, was feasible and maintained participant engagement over more than a year with no drop-outs.

The program led to a significant 27% reduction in COPD-related hospital costs, indicating potential benefits in healthcare utilization and positive feedback from participants about the service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. Zanaboni, P., Lien, LA., Hjalmarsen, A., et al.[2013]

An online education and support program for older patients with COPD was successfully implemented, showing high satisfaction among participants.

The program led to improvements in managing dyspnea, enhancing support, increasing self-efficacy, and promoting exercise among the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of an online dyspnea self-management program for COPD. Nguyen, HQ., Carrieri-Kohlman, V., Rankin, SA., et al.[2019]

A tele-rehabilitation program for COPD patients showed non-inferiority to standard rehabilitation in improving walking distance (6MWTD) after 8 weeks and maintained benefits at 3 and 6 months, with a 25% and 66% increase in walking distance, respectively.

The tele-rehabilitation approach demonstrated high patient adherence (81%) and satisfaction (average score of 4.27 out of 5), suggesting it could be an effective alternative to traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a New Tele-Rehabilitation Program versus Standard Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease. Cerdán-de-Las-Heras, J., Balbino, F., Løkke, A., et al.[2022]

Continued supervised maintenance exercise programs after pulmonary rehabilitation significantly reduce the risk of respiratory-cause hospital admissions in COPD patients, with a risk ratio of 0.62 based on data from 790 participants across eight trials.

While the evidence suggests a trend towards reduced exacerbations and mortality rates with supervised exercise, these outcomes did not reach statistical significance, indicating a need for further high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. Jenkins, AR., Gowler, H., Curtis, F., et al.[2018]

Citations

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Telehealth and Onsite Maintenance Exercise in Chronic Lung ... The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic ...