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Behavioural Intervention

Onsite Pulmonary Rehab for Chronic Obstructive Pulmonary Disease (COPD Trial)

N/A

Recruiting

Led By Shweta Gore, PhD

Research Sponsored by MGH Institute of Health Professions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4-month follow up

Awards & highlights

COPD Trial Summary

This trial aims to compare the effectiveness of a supervised exercise program delivered either onsite or through telehealth for adults with COPD. The study will evaluate outcomes such as breathlessness, exercise capacity, physical function

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves exercise programs rather than medication, side effects might include muscle soreness, fatigue from workouts or potential exacerbation of COPD symptoms due to increased activity levels.

COPD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4- month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4- month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4- month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dyspnea

Exercise Capacity

Physical Function

+1 more

Secondary outcome measures

Adverse events

Healthcare utilization

Inspiratory muscle strength

+3 more

COPD Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth Pulmonary RehabExperimental Treatment1 Intervention

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

Group II: Onsite Pulmonary RehabExperimental Treatment1 Intervention

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

Group III: ControlActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MGH Institute of Health ProfessionsLead Sponsor

15 Previous Clinical Trials

3,625 Total Patients Enrolled

Shweta Gore, PhDPrincipal InvestigatorMGH Institute of Health Professions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this medical research study?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking participants. The trial was initially posted on September 1st, 2023 and last modified on March 4th, 2024. It aims to enroll approximately 30 patients at a single site."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary objective of this investigation, to be assessed at a 4-month follow-up juncture, is the evaluation of Dyspnea. Supplemental endpoints encompass Healthcare utilization - denoted by the count of unscheduled physician visits or emergency room presentations, Adverse events such as falls and exacerbations, and PROMIS Global 10 score which gauges Quality of life through a multifaceted patient survey consisting of ten queries rated on diverse scales. The responses are utilized to compute both a Comprehensive Physical Health Score and an Emotional Well-being score that are aligned with population norms using T-Scores. In the general populace, an average T-S"

Answered by AI

Recent research and studies

European Respiratory JournalJournal

Development and First Validation of the COPD Assessment Test

Jones, P. W., G. Harding, P. Berry, I. Wiklund, W-H. Chen, and N. Kline Leidy. 2009. “Development and First Validation of the COPD Assessment Test”. European Respiratory Journal. European Respiratory Society (ERS). doi:10.1183/09031936.00102509.

clinicaltrials.govStudy

Telehealth and Onsite Maintenance Exercise in COPD

Shweta Gore 2023. "Telehealth and Onsite Maintenance Exercise in COPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06304207.

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