Cystic FibrosisNCT05157646
The Relationship Between CFTR Gene Mutations and Exercise Capacity
A study testing Fitness tracker in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Fitness tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Fitness tracker
- Keywords
- Exercise
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness trackerBehavioural
Participants will be asked to wear a Fitbit fitness tracker and report their fitness activity to the study team
| Study group | Role | What they receive |
|---|---|---|
| Exercise trackers | Experimental | Fitbit physical activity trackers Receives: Behavioral: Fitness tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly mileage
Participants will report their weekly mileage in a REDCap form
Measured: baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startAug 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Student was unable to start the project due to time constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Nauman Chaudary, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157646
- Sponsor's protocol ID
- HM20022243
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between CFTR Gene Mutations and Exercise Capacity
- ClinicalTrials.gov ID
- NCT05157646
- Acronym / sponsor ID
- HM20022243
- Conditions
- Cystic Fibrosis
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Student was unable to start the project due to time constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Aug 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise trackers | Experimental | Behavioral: Fitness trackerFitbit physical activity trackers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness trackerParticipants will be asked to wear a Fitbit fitness tracker and report their fitness activity to the study team | Behavioural | Exercise trackers |
Primary outcome
Change in weekly mileage
Time frame: baseline to 10 weeks
Participants will report their weekly mileage in a REDCap form
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nauman Chaudary, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness tracker in people with Cystic Fibrosis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly mileage (time frame: baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.