The Relationship Between CFTR Gene Mutations and Exercise Capacity

NCT05157646 | Withdrawn

• 1 other identifier: HM20022243
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Change in weekly mileage

  Participants will report their weekly mileage in a REDCap form

  baseline to 10 weeks

Study Arms (1)

Exercise trackers

EXPERIMENTAL

Fitbit physical activity trackers

Behavioral: Fitness tracker

Interventions

Fitness tracker BEHAVIORAL

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

Exercise trackers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Nauman Chaudary, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 15, 2021
• Study Start: August 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)