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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239611
• Other study ID #: KUMC STUDY00146919
• Status: Recruiting
• Phase: Phase 2
• Start date: February 14, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2022
• Source: University of Kansas Medical Center
• Contact: Joel Mermis, MD
• Phone: 9135886045
• Email: jmermis[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 our previous trials, we 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, we 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cystic fibrosis patients 18 years of age and older, confirmed diagnosis of CF (two CF mutations or sweat chloride > 60 mmol/L)

• stable while either on/off Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator therapy and no plan to start/discontinue CFTR modulator therapy

• clearance from their CF physician to participate in exercise

• have access to the internet

• not involved in an exercise intervention in the previous 6 months, and not performing structured exercise > 150 minutes per week.

Exclusion Criteria:

• pregnancy

• history of solid organ transplant

• active treatment for mycobacterial infections

• significant untreated hypoxemia, oxygen dependent at rest or with exercise

• FEV1 < 40% of predicted or clinical evidence of cor pulmonale

• untreated arterial hypertension (resting systolic blood pressure >140 mm Hg, diastolic blood pressure > 90 mmHg)

• systolic blood pressure less than 90 mm Hg while standing

• congestive heart failure

• active treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)

• acute upper or lower respiratory infection or pulmonary exacerbation within 4 weeks prior to Day 1

• changes in therapy (including antibiotics) for pulmonary disease within 4 weeks prior to Day 1

• significant hemoptysis within 4 weeks prior to Day 1 (= 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period

• ongoing participation in an investigational drug study within 60 days prior to Day 1

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Exercise
The 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiorespiratory fitness assessment- Modified shuttle Walk test result	completion of a modified shuttle walk test at enrollment and study completion	3 months
Primary	Ventilation defect percentage (VDP) as detected by 129Xenon MRI	Hyperpolarized 129Xe ventilation MRI will be performed to assess VDP at baseline (within 2 weeks of initiation of study) and after completion of the intervention/usual care-control period	3 months
Secondary	forced expiratory volume in 1 second	lung function will be assessed at enrollment and study completion	3 months
Secondary	quality of life assessment. Scale 0-100 (high score indicates better quality of life)	completion of the Cystic Fibrosis questionnaire-revised (CFQR)	3 months
Secondary	Exercise time	assess weekly adherence to prescribed exercise as percent prescribed exercise time completed	3 months