Feasibility of a New Model for Exercise Prescription in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Feasibility of a New Model for Exercise Prescription Combined With Behavior Modification in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075864
• Other study ID #: IRB-300003983
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Heather Hathorne, PhD
• Phone: 205-638-9568
• Email: hhathorne[@]peds.uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to begin an exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation. The exercise program will begin during the hospital stay. Beginning an exercise program during this period of reduced mobility and isolation may be an ideal time to deliver a structured exercise prescription along with a behavioral program to promote long-term adherence to exercise (structured physical activity) . Hospitalized patients have an acute awareness that their lung function is declining and may be more motivated and open to changing their behavior and adding exercise to their treatment regimen.

Description:

During the hospitalization (T0 to T1; Figure 1, next page), participants will perform supervised exercise 6 days/wk. On each of these days, there will be a 5-10 min warm up consisting of low intensity execises for lower and upper exermity muscles. The total time per week will be between 2.5 and 3.5 hours.

Three days/wk will consist of aerobic exercise ("frequency"). The various "modes (types)" for this exercise include 1) overground ambulation (including stairs), 2) treadmill ambulation, 3) stationary cycling, or 4) repetitive body-weight exercises (e.g., "jumping jacks"). The "time (duration)" of these sessions will be 20-30 min/day. The "intensity" will be moderate (40-60% of heart rate reserve and/or perceived dyspnea/exertion of 3-5) to vigogous (60-85% of heart rate reserve and/or perceived dyspnea/exertion of 6-8). Participants will be given a HR monitor and specific "target" HR ranges based on their resting HR in standing and their age predicted maximal HR (NOTE: maximal exercise testing will not be performed); they will also be familiarized and instructed in use of the Borg CR10 scale to rate perceived dyspnea/exertion Participants should be able to "talk comfortably" during moderate intensity exercise, while talking should be "somewhat challenging" during vigorous efforts; HR, as well as perceived exertion/dyspnea and "talk test" will be monitored throughout each supervised session by trained personnel.

On alternate days, participants will perform supervised resistance exercise training (3 days/wk; "frequency"). The various "modes (types)" for this exercise include 1) body-weight exercises (e.g., lunges, squats, jumping, situps, pushups) and/or 2) resistance bands and dumbbells; exercises will target upper extremity, trunk/core, and lower extremity muscles (NOTE: specific inspiratory muscle training will not be performed). The "intensity" of these exercises will be at approximately 12-15 repetition max (that is, on the 3rd set of an exercise, the participant should have difficulty performing more than 12-15 quality (good form) repetitions of the exercise. An appropriate number of exercises will be selected such that the exercise "duration (time)" will be 20-30 min/day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of CF

2. 18 years old or older

3. Current pulmonary exacerbation with planned UAB hospitalization for at least 10 days

4. Willing to participate in a regular, ongoing exercise program

5. Access to broadband internet

Exclusion Criteria:

1. Currently exercising more than 60 min/week

2. Massive hemoptysis or pneumothorax in past 3 months

3. Neuromusculoskeletal impairments that preclude exercise

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Behavioral Counseling and Exercise
exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary function	forced expiratory volume in 1 second	1 year