Feasibility of a New Model for Exercise Prescription in Cystic Fibrosis

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04075864
Collaborator
(none)
12
1
1
33
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Counseling and Exercise
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility of a New Model for Exercise Prescription Combined With Behavior Modification in Cystic Fibrosis
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: behavioral intervention to improve physical activity

The proposed study is prospective single-arm feasibility clinical trial that will enroll 12 hospitalized patients with CF in accordance with consensus criteria. Standard care for an acute CF exacerbation includes i.v. antibiotics and airway clearance therapies for 10-14 days. Routine care following hospitalization is an outpatient CF clinic visit 2-4 weeks after discharge, and then regular follow up every 2-3 months. In addition, to standard care in the hospital, study participants will receive a 1) tailored exercise prescription, 2) daily, individual, supervised, aerobic and strength/power training, as well as 3) daily behavioral counseling focused on topics related to long-term adherence to exercise (details below).

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

Outcome Measures

Primary Outcome Measures

  1. pulmonary function [1 year]

    forced expiratory volume in 1 second

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Stefanie Krick, MD, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stefanie Krick MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04075864
Other Study ID Numbers:
  • IRB-300003983
First Posted:
Sep 3, 2019
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021