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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am going to be hospitalized for a lung problem for at least 10 days.
Select...
I am 18 years old or older.
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I have been diagnosed with cystic fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pulmonary function
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).
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,470 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am going to be hospitalized for a lung problem for at least 10 days.You are willing to commit to a regular exercise program throughout the study.You need to have high-speed internet to participate in the study.You are currently exercising for more than 1 hour per week.I am 18 years old or older.You have a physical condition that prevents you from exercising.I have not had severe coughing up of blood or lung collapse in the last 3 months.I have been diagnosed with cystic fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: behavioral intervention to improve physical activity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for this investigation?
"Clinicaltrials.gov confirms that the search for potential candidates is still ongoing; this research study was initially announced on December 1st 2020, with its most recent update being posted on October 31st 2022."
Answered by AI
To what extent is this clinical trial being utilized by participants?
"Affirmative. As per the details found on clinicaltrials.gov, this investigation is still actively seeking participants and can trace its start date to December 1st 2020. The trial is currently trying to acquire 12 individuals from one site of enrolment."
Answered by AI
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