Quality of LifeNCT03122418
Use of Personal Fitness Device in Adult (> 21 Years Old) Patients With Cystic Fibrosis
A study testing Personal Fitness Device in people with Quality of Life, run by University of Oklahoma at 1 site in United States.
Trial summary
Approximately half of the variation in the presentation and disease status of patients with Cystic Fibrosis (CF) is secondary to non-genetic variables.[1] These include household income, compliance with therapy, second hand smoke exposure and possibly exercise (although exercise has less evidence to support its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Personal Fitness Device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to 1 Feb 2019
- 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
- diagnosis of CF,
- age of 21 or older,
- willingness to consider some type of routine exercise,
- BMI above 18 if female and above 20 for males,
- willing to wear personal fitness device daily and
- not already preforming daily exercise routinely
Who cannot join
- patients who are unable or unwilling to understand and sign consent for this study,
- patients who the study physicians determine it would not be safe to ask them to exercise,
- patients who are not expected to survive over the next 12 months,
- patients who are non-compliant and will not comply with study visits and procedures,
- patients currently participating in other research trials,
- patients who have had an acute exacerbation of their cystic fibrosis (treatment with oral or IV antibiotics) within the last 30 days,
- patients with significant room air hypoxia who require more than 4 liters by nasal cannula to improve oxygenation to more than 90%.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Approximately half of the variation in the presentation and disease status of patients with Cystic Fibrosis (CF) is secondary to non-genetic variables.[1] These include household income, compliance with therapy, second hand smoke exposure and possibly exercise (although exercise has less evidence to support its influence on disease status). Recently increased attention has been focused on the role of exercise and quality of life for patients with CF. This study will evaluate the role of exercise in relation to the patient's perception of their quality of life. The primary outcome will be the overall change in the patient's Cystic Fibrosis Questionnaire - Revised (CFQ-R) over a one year period during which the participants are encouraged to exercise and use a personal fitness device to track their exercise. This is a prospective single group non-blinded study. Participants will be asked to wear a personal fitness device for 11-13 months. The change in CFQ-R score is the primary outcome and other secondary outcomes will include; (1) exacerbations of cystic fibrosis (through use of antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI and (5) change in 6 minute walk test. The study will take place at the Adult CF Clinic on the University of Oklahoma Health Sciences Center campus.
Read the detailed description
The specific aim of this study is to evaluate the use of personal fitness devices inpatients with cystic fibrosis over the age of 21.
The primary outcome will be the overall change in the patient's Cystic Fibrosis Questionnaire - Revised (CFQ-R) over a one year period. Secondary outcomes will evaluate (1) exacerbations of cystic fibrosis (through use of antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI and (5) change in 6 minute walk test
This is a prospective single group non-blinded study. Participants will be asked to wear a personal fitness device for 11-13 months (this will be the duration of their enrollment in the study). Upon enrollment, subjects will be given information regarding the benefits of physical activity and encouraged to develop an initial individual fitness goal. Two specific handouts regarding the benefits and how to start and exercise routine will be provided.
They will not be given a specific exercise program to follow, but instead will be encouraged to set personal fitness goals over the year and use the device to track these individual goals. Although they will be encouraged to have an individualized goal each participant will be asked to take a minimum of 5,000 steps per day during the first three months over the study and increase to 10,000 steps over the one year study period. This goal can be achieved by walking, aerobic classes or other exercise modalities, the method of exercise is expected to be variable for each participating subject and based on their personal preferences. Study participants individual goals will be noted by study staff during in the clinic visit in the electronic medical record. The personal fitness device to be used as part of this study is the Garmin Vivofit 2 fitness activity and sleep tracker.
- Conditions
- Quality of Life
- Being tested
- Personal Fitness Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Fitness DeviceBehavioural
Subjects will be given a personal fitness device to use to encourage exercise routinely. The impact this has on the individual perception of their quality of life will be the primary outcome for this study
| Study group | Role | What they receive |
|---|---|---|
| Exercise Study Group | Experimental | All subjects in this study will receive a personal fitness device and be asked to participate in some routine exercise. Each participant will be compared to their own initial CFQ-R score (to measure quality of life) before and after use of the personal fitness device. Receives: Behavioral: Personal Fitness Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life for individuals with CF using a personal fitness device
Will be measured using the CFQ-R questionnaire (a standard questionnaire for CF patients)
Measured: Will be completed upon enrollment and at 6 months and 12 months
Secondary outcomes (1)
Walking distance
Evaluate by a 6 minute walk test
Measured: This will be done upon enrollment, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start18 Apr 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive a personal fitness device and asked to develop an individual exercise program.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen S Allen, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122418
- Sponsor's protocol ID
- 7754
- Status last verified
- Feb 2024
- First submitted
- 17 Apr 2017
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Initial data analysis was clear that study completion would not lead to a statistically significant difference in the primary outcome. Data are available and may be obtained through written request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Personal Fitness Device in Adult (> 21 Years Old) Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03122418
- Acronym / sponsor ID
- 7754
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 20 Apr 2017 (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.
Approximately half of the variation in the presentation and disease status of patients with Cystic Fibrosis (CF) is secondary to non-genetic variables.[1] These include household income, compliance with therapy, second hand smoke exposure and possibly exercise (although exercise has less evidence to support its influence on disease status). Recently increased attention has been focused on the role of exercise and quality of life for patients with CF. This study will evaluate the role of exercise in relation to the patient's perception of their quality of life. The primary outcome will be the overall change in the patient's Cystic Fibrosis Questionnaire - Revised (CFQ-R) over a one year period during which the participants are encouraged to exercise and use a personal fitness device to track their exercise. This is a prospective single group non-blinded study. Participants will be asked to wear a personal fitness device for 11-13 months. The change in CFQ-R score is the primary outcome and other secondary outcomes will include; (1) exacerbations of cystic fibrosis (through use of antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI and (5) change in 6 minute walk test. The study will take place at the Adult CF Clinic on the University of Oklahoma Health Sciences Center campus.
Detailed description
The specific aim of this study is to evaluate the use of personal fitness devices inpatients with cystic fibrosis over the age of 21.
The primary outcome will be the overall change in the patient's Cystic Fibrosis Questionnaire - Revised (CFQ-R) over a one year period. Secondary outcomes will evaluate (1) exacerbations of cystic fibrosis (through use of antibiotics), (2) change in subject's FEV1, (3) inpatient admission rates, (4) change in BMI and (5) change in 6 minute walk test
This is a prospective single group non-blinded study. Participants will be asked to wear a personal fitness device for 11-13 months (this will be the duration of their enrollment in the study). Upon enrollment, subjects will be given information regarding the benefits of physical activity and encouraged to develop an initial individual fitness goal. Two specific handouts regarding the benefits and how to start and exercise routine will be provided.
They will not be given a specific exercise program to follow, but instead will be encouraged to set personal fitness goals over the year and use the device to track these individual goals. Although they will be encouraged to have an individualized goal each participant will be asked to take a minimum of 5,000 steps per day during the first three months over the study and increase to 10,000 steps over the one year study period. This goal can be achieved by walking, aerobic classes or other exercise modalities, the method of exercise is expected to be variable for each participating subject and based on their personal preferences. Study participants individual goals will be noted by study staff during in the clinic visit in the electronic medical record. The personal fitness device to be used as part of this study is the Garmin Vivofit 2 fitness activity and sleep tracker.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive a personal fitness device and asked to develop an individual exercise program.
| Arm | Type | Receives |
|---|---|---|
| Exercise Study Group | Experimental | Behavioral: Personal Fitness DeviceAll subjects in this study will receive a personal fitness device and be asked to participate in some routine exercise. Each participant will be compared to their own initial CFQ-R score (to measure quality of life) before and after use of the personal fitness device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of CF,
- age of 21 or older,
- willingness to consider some type of routine exercise,
- BMI above 18 if female and above 20 for males,
- willing to wear personal fitness device daily and
Key exclusion criteria (7 listed)
- patients who are unable or unwilling to understand and sign consent for this study,
- patients who the study physicians determine it would not be safe to ask them to exercise,
- patients who are not expected to survive over the next 12 months,
- patients who are non-compliant and will not comply with study visits and procedures,
- patients currently participating in other research trials,
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 |
|---|---|---|
| Personal Fitness DeviceSubjects will be given a personal fitness device to use to encourage exercise routinely. The impact this has on the individual perception of their quality of life will be the primary outcome for this study | Behavioural | Exercise Study Group |
Primary outcome
Change in quality of life for individuals with CF using a personal fitness device
Time frame: Will be completed upon enrollment and at 6 months and 12 months
Will be measured using the CFQ-R questionnaire (a standard questionnaire for CF patients)
1 secondary outcome
Walking distance
Time frame: This will be done upon enrollment, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No. Initial data analysis was clear that study completion would not lead to a statistically significant difference in the primary outcome. Data are available and may be obtained through written request to the PI.
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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.
Karen S Allen, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Fitness Device in people with Quality of Life, run by University of Oklahoma 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 quality of life for individuals with CF using a personal fitness device (time frame: Will be completed upon enrollment and at 6 months and 12 months). 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 15 Feb 2024.