The Relationship Between CFTR Gene Mutations and Exercise Capacity

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05157646
Collaborator
Cystic Fibrosis Foundation (Other)
50
1
1
3
16.5

Study Details

Study Description

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
  • Behavioral: Fitness tracker
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in weekly mileage [baseline to 10 weeks]

    Participants will report their weekly mileage in a REDCap form

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Nauman Chaudary, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05157646
Other Study ID Numbers:
  • HM20022243
First Posted:
Dec 15, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
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
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022