Exercise Programs for COPD

(CLD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Shweta Gore, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: MGH Institute of Health Professions

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease. The specific aims of the study are: * To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention. * To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation. Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.

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 data supports the effectiveness of this treatment for COPD?

Research shows that pulmonary rehabilitation programs, including home-based and telehealth approaches, can improve exercise capacity and quality of life for COPD patients. Tele-rehabilitation has been found to be as effective as standard rehabilitation, with high patient satisfaction and adherence. ^{1 2 3 4 5}

Is exercise therapy safe for people with COPD?

Exercise programs, including telerehabilitation and unsupervised training at home, have been shown to be safe for people with COPD, with no major adverse events reported in studies. These programs can reduce hospital visits and improve health status, making them a safe option for managing COPD. ^{3 5 6 7 8}

How is the Exercise Programs for COPD treatment different from other treatments for COPD?

This treatment is unique because it combines onsite and telehealth exercise programs, allowing patients to exercise at home with remote supervision and support, which can reduce hospital visits and healthcare costs. It includes the use of technology like videoconferencing and online diaries to monitor progress, making it more accessible and convenient for patients compared to traditional in-person rehabilitation programs. ^{3 4 7 9 10}

Research Team

Shweta Gore, PhD

Principal Investigator

MGH Institute of Health Professions

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Onsite Maintenance Exercise Training (Behavioural Intervention)
• Telehealth Maintenance Exercise (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of a Home-Based Manual as Part of a Pulmonary Rehabilitation Program. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of a New Tele-Rehabilitation Program versus Standard Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Ventilatory and nonventilatory muscle exercise in COPD rehabilitation. [2008]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Advanced telehealth technology improves home-based exercise therapy for people with stable chronic obstructive pulmonary disease: a systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term Telerehabilitation or Unsupervised Training at Home for Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot study of an online dyspnea self-management program for COPD. [2019]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. [2013]

10. Canada pubmed.ncbi.nlm.nih.gov

Conceptual validation of an innovative remote pulmonary rehabilitation solution for Chronic Obstructive Pulmonary Disease. [2022]