General Health, Attitudes, and Activity in Self-directed Exercise in Patients With Cystic Fibrosis (GAINS-CF)

NCT04882267 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-05-11

No results posted yet for this study

Summary

Exercise helps people with CF lead long, fulfilling lives. Regular exercise reduces depression and fatigue, and may play a role in preventing exacerbation. However, little is known about exercise habits in adults with CF, or the barriers to exercise that they face.

During the COVID-19 pandemic, lockdowns and social distancing saw gym memberships plummet; while sale of personal exercise technology, smart-watches, and interactive home equipment exploded. As this technology becomes more cost-effective and accessible, can it be leveraged to improve CF care? This study will examine barriers to exercise in CF and the role of smart devices in exercise. Adults with CF will participate in the Exercise Behaviors/Barriers Survey, followed by a qualitative discussion on attitudes toward exercise technology, and how CF impacts exercise. We anticipate that many perceived barriers will be universal (e.g. time), while others will be unique to CF.

Participants will be fitted with wrist actigraphy (FitBit Inspire 2) to measure baseline exercise. They will receive access to three smartphone apps designed for home exercise, as well as an exercise website designed for the CF community (www.activate65.org), and receive weekly phone calls from the CF care team offering motivational interviewing. Actigraphy, heart and respiratory rate, and app usage will be analyzed. After four weeks, participants will no longer receive calls. Actigraphy will be monitored four additional weeks to determine if exercise is sustained. We anticipate that exercise will increase during the intervention period, and that some activity will be sustained in the follow up period.

The findings of this study will pave the way for a larger trial using this "Team and Technology" approach to investigate clinical outcomes. This study highlights the critical and timely need to investigate the barriers to exercise in CF, and effective solutions to develop sustainable exercise habits using widely-available technology from home.

Conditions

Interventions

BEHAVIORAL

Team and Technology

Subjects will receive access and instruction on multiple home exercise apps. They will receive phone calls once a week from care team members for motivational interviewing to encourage exercise.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Lindsay Somerville, MD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2023-05-31
Completion
2023-05-31

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882267 on ClinicalTrials.gov