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Behavioral Counseling + Exercise for Cystic Fibrosis

N/A
Recruiting
Led By Stefanie Krick, MD, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current pulmonary exacerbation with planned UAB hospitalization for at least 10 days
18 years old or older
Must not have
Massive hemoptysis or pneumothorax in past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if starting an exercise program while in the hospital helps patients with cystic fibrosis.

Who is the study for?
This trial is for adults over 18 with Cystic Fibrosis who are currently hospitalized for a pulmonary exacerbation and will stay in the hospital for at least 10 days. They must have internet access, be willing to start an exercise program, and not already exercising more than 60 minutes per week. Those with recent severe lung complications or physical impairments that prevent exercise cannot join.
What is being tested?
The study tests a new approach combining exercise with behavioral counseling during hospitalization for Cystic Fibrosis patients. The goal is to see if starting this regimen when patients are acutely aware of their health can improve long-term adherence to regular physical activity.
What are the potential side effects?
Since the intervention involves exercise and counseling rather than medication, side effects may include typical responses to new physical activities such as muscle soreness or fatigue but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am going to be hospitalized for a lung problem for at least 10 days.
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I am 18 years old or older.
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I have been diagnosed with cystic fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had severe coughing up of blood or lung collapse in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
pulmonary function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: behavioral intervention to improve physical activityExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,372 Total Patients Enrolled
22 Trials studying Cystic Fibrosis
41,077 Patients Enrolled for Cystic Fibrosis
Stefanie Krick, MD, PhDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham

Media Library

Behavioral Counseling and Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04075864 — N/A
Cystic Fibrosis Research Study Groups: behavioral intervention to improve physical activity
Cystic Fibrosis Clinical Trial 2023: Behavioral Counseling and Exercise Highlights & Side Effects. Trial Name: NCT04075864 — N/A
Behavioral Counseling and Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075864 — N/A
~0 spots leftby Dec 2024