The Relationship Between CFTR Gene Mutations and Exercise Capacity

Cystic Fibrosis Clinical Trial

Official title:

The Relationship Between CFTR Gene Mutations and Exercise Capacity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05157646
• Other study ID #: HM20022243
• Status: Withdrawn
• Phase: N/A
• Start date: August 2022
• Est. completion date: November 2022

Study information

• Verified date: September 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Behavioral:
• Fitness tracker
Participants will be asked to wear a Fitbit fitness tracker and report their fitness activity to the study team

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weekly mileage	Participants will report their weekly mileage in a REDCap form	baseline to 10 weeks