NCT04882267: GAINS-CF

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

Status unknown NA Last updated 11 May 2021

What this trial tests

NA trial testing Team and Technology in Cystic Fibrosis in 12 participants. Status unknown.

Timeline

31 May 2021

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	31 May 2021
Primary completion	31 May 2023
Estimated completion	31 May 2023

Drugs / interventions tested

• Team and Technology

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.