NCT05239611

Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis

Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of Ventilation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this clinical pilot study is to evaluate the feasibility and impact of a home-based exercise program on clinical and patient-centered outcomes in adult with cystic fibrosis (CF) and inform the design of a larger clinical trial.

Detailed description

This pilot and feasibility study is a randomized controlled trial comparing exercise intervention with a usual care group. Participants will be randomized based on a randomization table developed by a biostatistician who is not involved in the study. The exercise intervention group will be delivered with a telehealth platform using internet (Zoom HIPAA-Compliant video), an app, phone, and email/text support. Participants will be randomly allocated to either an exercise coaching program or a usual care arm. The exercise intervention arm will follow guidelines established by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and complement best clinical practices established by the American Thoracic Society/European Respiratory Society (ATS/ERS). The usual care arm will be provided a handout on resources for engaging in physical activity. Aim 1. Examine the feasibility of a home-based Tele-rehab intervention. Indicators of feasibility will include recruitment and adherence. Hypothesis 1: Based on previous trials, the investigators predict that \>50% of eligible participants will consent to the study. Hypothesis 2: Again, based on previous trials, \>70% of participants in the intervention arm will adhere to \>70% of their weekly prescribed exercise. Also, the investigators will assess reasons for; 1) eligible patients who don't enroll, 2) participants' non-adherence, and 3) non-completers. Aim 2. Evaluate the impact of a home-based exercise program in adults with CF for improving clinical and patient-centered outcomes. Hypothesis 1: There will be a greater improvement in exercise capacity (measured by a modified shuttle test), a novel measure of lung function 129Xenon MRI (129Xe MRI), forced expiratory volume in 1 second (FEV1), and quality of life with participants in the intervention arm when compared to usual care. Hypothesis 2: Changes in exercise capacity and 129Xe MRI will be associated with exercise adherence, as noted in Aim 1.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Xenon MRI	Study participants will be randomized to a 12 week exercise intervention versus usual care. Participants will have Xenon MRI at study start and completion to evaluate impact of exercise on lung function. The exercise intervention for all participants will be delivered by two pulmonary rehabilitation coaches (PR-coach) including a registered respiratory therapist and clinical registered dietitian who've been trained in exercise training as recommended by the AACVPR and American College of Sports Medicine (ACSM). Each TR participant will be assigned a PR-coach, and receive one weekly exercise consulting session during the 12-week intervention.

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-08-03
• Completion: 2023-08-03
• First posted: 2022-02-15
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study