Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06304207

Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease: A Pilot Randomized Controlled Trial

Led by MGH Institute of Health Professions · Updated on 2024-08-01

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial studies adults aged 40 and older with Chronic Lung Disease who have recently completed traditional outpatient rehabilitation or physical therapy. It aims to compare the effects of an 8-week supervised maintenance exercise program delivered onsite, via telehealth, or no maintenance on breathing difficulty, exercise capacity, physical function, activity levels, and quality of life at 8 weeks and 4 months after intervention. The study is a randomized controlled pilot trial led by the MGH Institute of Health Professions. Participants are randomly assigned to one of three groups: onsite maintenance exercise, telehealth maintenance exercise, or a control group with no active intervention. Both exercise groups receive weekly 60-minute supervised sessions including inspiratory muscle training, education, warm-up, aerobic training tailored to individual capacity, functional strength exercises, and cool-down. The telehealth group participates remotely via Zoom using tablets loaned if needed. Control participants receive biweekly check-in calls and general home exercise instructions. All participants complete assessments at baseline, after 8 weeks, and at 4 months post-intervention. Evaluations include breathlessness scales, physical function tests, a six-minute walk test, physical activity questionnaires, quality of life surveys, inspiratory muscle strength, and vital signs. Researchers monitor adherence, healthcare use, and adverse events throughout. Participants keep activity logs, receive educational materials, and are compensated for their time. Safety precautions and study withdrawal options are clearly outlined.

CONDITIONS

Brief Title

Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 years and older with physician-diagnosed Chronic Lung Disease within 2 months of discharge after completing traditional onsite outpatient rehabilitation, physical therapy, or exercise program
  • Able to walk independently with or without mobility devices
  • Able to complete a six-minute walk test at discharge maintaining oxygen saturation at or above 85%, with or without supplemental oxygen
  • Able to understand and follow instructions in English
  • Have the ability to connect to the internet
Not Eligible

You will not qualify if you...

  • Significant mobility limitations due to stroke, neurological diseases like Parkinson's or multiple sclerosis, severe osteoarthritis, or joint impairments affecting walking ability
  • Primary reliance on a wheelchair for mobility
  • Unable to complete a walking test without oxygen saturation dropping below 85% at discharge
  • Baseline hemodynamic compromise, unstable angina, recent heart attack within a week, uncontrolled atrial fibrillation, advanced heart failure (NYHA class 4), or use of mechanical heart assist devices
  • Inability to communicate in English

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (phone screening and consent process, followed by initial onsite visit for baseline assessments)

Treatment

Duration - 8 weeks

Participants in the onsite and tele-rehab groups receive supervised weekly exercise sessions for 8 weeks. Control group participants receive no active supervised intervention but are encouraged to maintain a home exercise routine with bi-weekly phone check-ins to support engagement.

Weekly supervised exercise visits for onsite and tele-rehab groups; bi-weekly phone calls for control group

Follow-up

Duration - Approximately 3 months after treatment

Participants are assessed for outcomes at 4 months after the end of the intervention period to monitor long-term effects.

1 visit for outcome assessment at 4 months post-intervention

Trial Site Locations

Total: 1 location

1

MGH Institute of Health Professions

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

S

Shweta Gore, PhD

J

Jane Baldwin, DPT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation.

Carolyn L Rochester, Ioannis Vogiatzis, Anne E Holland...

https://pubmed.ncbi.nlm.nih.gov/26623686

Optimizing pulmonary rehabilitation in chronic obstructive pulmonary disease--practical issues: a Canadian Thoracic Society Clinical Practice Guideline.

Darcy D Marciniuk, Dina Brooks, Scott Butcher...

https://pubmed.ncbi.nlm.nih.gov/20808973

Managing dyspnea in patients with advanced chronic obstructive pulmonary disease: a Canadian Thoracic Society clinical practice guideline.

Darcy D Marciniuk, Donna Goodridge, Paul Hernandez...

https://pubmed.ncbi.nlm.nih.gov/21499589

An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation.

Martijn A Spruit, Sally J Singh, Chris Garvey...

https://pubmed.ncbi.nlm.nih.gov/24127811

A randomized controlled trial of telephone-mentoring with home-based walking preceding rehabilitation in COPD.

Helen Laura Cameron-Tucker, Richard Wood-Baker, Lyn Joseph...

https://pubmed.ncbi.nlm.nih.gov/27601892

Supervised maintenance programmes following pulmonary rehabilitation compared to usual care for chronic obstructive pulmonary disease.

Carla Malaguti, Simone Dal Corso, Sadia Janjua...

https://pubmed.ncbi.nlm.nih.gov/34404111