Physical Activity Clinical Trial
Official title:
TAME Health: Testing Activity Monitors' Effect on Health
NCT number | NCT02554435 |
Other study ID # | 15-0014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | September 2016 |
Verified date | May 2018 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 74 Years |
Eligibility |
Inclusion Criteria: - physically inactive (less than 60 minutes per week) - BMI between 25-35 - in good health measured by Par-Q+ - access to a smart phone Exclusion Criteria: - physical activity is inadvisable by their doctor - involved in another physical activity intervention within the past 6 months - used an activity monitor in the past 6 months - unwilling to travel for scheduled visits - currently taking medications that affect body composition - current smoker - report alcohol or drug problem - institutionalized for psychiatric illness within the last year - do not consent |
Country | Name | City | State |
---|---|---|---|
United States | Primary Care Pavilion | Galveston | Texas |
United States | Victory Lakes Town Center | League City | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | American Heart Association |
United States,
Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Lyons EJ. Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients. JMIR Res Protoc. 2016 Apr 29;5(2):e59. doi: 10.2196/resprot.5454. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity Minutes Measured by a SenseWear Armband | Minutes of moderate-vigorous physical activity over a 7 day period | Physical activity minutes at the end of the 12 week intervention | |
Primary | Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator | Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to >30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to >30% risk of a cardiovascular event within the next 10 years. | Cardiovascular risk at the end of the 12 week intervention | |
Primary | 6-minute Walk Test | distance walked in 6 minutes | Fitness at the end of the 12 week intervention | |
Primary | Steps Per Day | Measured by a SenseWear Armband. Average steps per day over a 7 day period | Steps per day at the end of the 12 week intervention | |
Secondary | Weight | Weight at the end of the 12 week intervention | ||
Secondary | Body Mass Index (BMI) | BMI at the end of the 12 week intervention | ||
Secondary | Waist-to-Hip Ratio | Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches). | Waist-to-hip ratio at the end of the 12 week intervention | |
Secondary | Blood Pressure | Blood pressure at the end of the 12 week intervention | ||
Secondary | Exercise Motivation | Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of "intrinsic" and "identified" are better. Alternatively, low scores of "introjected", "extrinsic", and "amotivation" are better. | Exercise motivation at the end of the 12 week intervention | |
Secondary | Quality of Life Measured by the SF-36 Questionnaire | Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale. | Quality of life at the end of the 12 week intervention | |
Secondary | Physical Function Measured by the Short Physical Performance Battery | Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled "tandem balance." | Physical function at the end of the 12 week intervention | |
Secondary | Psychological Feelings | Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome. | Psychological feelings at the end of the 12 week intervention | |
Secondary | Resting Pulse | Resting pulse at the end of the 12 week intervention | ||
Secondary | Change From Baseline in Self-regulation | Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning. | Change in self-regulation from baseline and 12-weeks |
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