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

NCT03122418 | Completed DMC

• 1 other identifier: 7754
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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)

  Will be completed upon enrollment and at 6 months and 12 months

Secondary Outcomes (1)

• Walking distance

  This will be done upon enrollment, 6 months and 12 months

Study Arms (1)

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.

Behavioral: Personal Fitness Device

Interventions

Personal Fitness Device BEHAVIORAL

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

Exercise Study Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Karen S Allen, MD

  OUHSC

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Subjects will receive a personal fitness device and asked to develop an individual exercise program.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: April 18, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)