Clinical trial NCT03122418: Use of Personal Fitness Device in Adult (> 21 Years Old) Patients With Cystic Fibrosis
Official title: Use of Personal Fitness Device in Adult (> 21 Years Old) Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will receive a personal fitness device and asked to develop an individual exercise program.
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of CF,
2. age of 21 or older,
3. willingness to consider some type of routine exercise,
4. BMI above 18 if female and above 20 for males,
5. willing to wear personal fitness device daily and
6. not already preforming daily exercise routinely

Exclusion Criteria:

1. patients who are unable or unwilling to understand and sign consent for this study,
2. patients who the study physicians determine it would not be safe to ask them to exercise,
3. patients who are not expected to survive over the next 12 months,
4. patients who are non-compliant and will not comply with study visits and procedures,
5. patients currently participating in other research trials,
6. patients who have had an acute exacerbation of their cystic fibrosis (treatment with oral or IV antibiotics) within the last 30 days,
7. patients with significant room air hypoxia who require more than 4 liters by nasal cannula to improve oxygenation to more than 90%.

Primary outcomes:
measure: Change in quality of life for individuals with CF using a personal fitness device
timeFrame: Will be completed upon enrollment and at 6 months and 12 months
Secondary outcomes:
measure: Walking distance
timeFrame: This will be done upon enrollment, 6 months and 12 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Karen S Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: