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The Relationship Between CFTR Gene Mutations and Exercise Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05157646
Recruitment Status : Not yet recruiting
First Posted : December 15, 2021
Last Update Posted : February 7, 2022
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This study will explore the effect of mutation severity on exercise capacity. Through a better understanding of the association between mutation severity and exercise capacity, clinicians will be more able to predict a given patient's level of independent functioning based on their genes, which is essential information that patients' families want to know upon diagnosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Fitness tracker Not Applicable

Detailed Description:

Cystic fibrosis (CF) is a disease that disrupts the lungs. With an average survival of 40.7 years, this condition affects around 30,000 in the US. Most commonly seen in among those of European descent, CF is present in about 1 in every 2,500 Caucasian newborns. A genetic mutation causes a thick and sticky mucus production in the lungs. Thus, CF patients are more likely to have respiratory failure and lung infections. These symptoms of CF vary among patients and primarily depend on the severity of the gene mutations.Currently, there is not a lot of literature on the relationship between CFTR genes and exercise capacity, highlighting the relevance of this study.

This study is expected to last at least 10 weeks. Participants will be given a Fitbit tracker at the beginning of the study to wear during their participation. Participants are asked to engage in their normal level of physical activity. No one from the research team will have direct access to their Fitbit information. In other words, participants will create an account on the Fitbit website and only participants will be able to see the information on there. A weekly survey about their Fitbit mileage will be given by a research member via phone. The weekly survey will also ask more opinionated questions, regarding any updates on their attitudes toward exercise. At the conclusion of this 10-week study, participants will have the option of keeping their Fitbit tracker. About 50 participants are expected to enroll in this study. At any point of the study, participants will be given the freedom to withdraw their participation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Relationship Between CFTR Gene Mutations and Exercise Capacity
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Exercise trackers
Fitbit physical activity trackers
Behavioral: Fitness tracker
Participants will be asked to wear a Fitbit fitness tracker and report their fitness activity to the study team




Primary Outcome Measures :
  1. Change in weekly mileage [ Time Frame: baseline to 10 weeks ]
    Participants will report their weekly mileage in a REDCap form



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cystic fibrosis patient who has been tested positive for a CF mutation of class 1-5.
  • Part of the VCU cystic fibrosis program.
  • Above 18 years old.

Exclusion Criteria:

  • Has not been tested positive for a known CF mutation.
  • Not a part of the VCU cystic fibrosis program.
  • Cannot be under 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05157646


Contacts
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Contact: Betty Ma 804-828-1579 mabc@vcu.edu
Contact: Chaudary Nauman, MD 804-828-9071 nachaudary@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Nauman Chaudary, MD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT05157646    
Other Study ID Numbers: HM20022243
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Exercise
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases