Use of Personal Fitness Device in Adult (> 21 Years Old) Patients With Cystic Fibrosis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:April 18, 2017
End Date:December 31, 2019
Contact:Karen Allen, MD
Email:karen-allen@ouhsc.edu
Phone:405-271-6173

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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.

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.

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%.
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-6173
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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mi
from
Oklahoma City, OK
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