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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00747019
Other study ID # AG0106
Secondary ID 1R21AG027413-01A
Status Recruiting
Phase N/A
First received September 3, 2008
Last updated June 30, 2009
Start date December 2008
Est. completion date June 2010

Study information

Verified date June 2009
Source National Institute on Aging (NIA)
Contact Carol Massa-Fanale, MS
Phone 336-716-3589
Email cmassa@wfubmc.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two exercise programs to determine how well they help older adults make exercise a regular habit after 9 months.


Description:

Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.

Both the Prosocial Behavior Physical Activity (PBPA) group and the Physical Exercise (PE) group will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (9-month) independent physical activity. Both programs will provide supervised exercise sessions so that participants learn how to safely and effectively engage in physical activity, and both programs will help participants set goals for activity and overcome barriers to exercise. However, in PBPA group, participants will be able to also earn boxes of food for donation to a charity based upon their physical activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria:

- Between 55 and 80 years of age

- Physically underactive (moderate or vigorous physical activity for less than 2 days per week for the preceding 3 months)

- No evidence of any major psychological illness

- Written permission from the participant's primary care physician with specific certification of no severe risk of cardiovascular disease

- Participant resides within a 35-mile radius of the study site

- Participant will remain in the area for the duration of the study

Exclusion Criteria:

- Self-reported evidence of cardiovascular disease risk, or documentation by the primary care physician of at least one of the following within the past 5 years:

- Myocardial infarction (MI)

- Percutaneous transluminal coronary angioplasty (PTCA)

- Chronic or unstable angina at rest or during physical exertion

- New York Heart Association (NYHA) Type I through Type IV congestive heart failure

- Unstable ventricular arrhythmias

- Cardiovascular surgery (coronary artery or valvular heart disease)

- Ischemic or hemorrhagic stroke

- Intermittent claudication during physical activity

- Edema in feet

- Self-reported or documented evidence of rheumatoid arthritis

- Self-reported or physician-reported evidence of current cigarette or cigar smoking

- Self-reported treatment for psychiatric illness within the past 5 years:

- Treatment for major depression or schizophrenia

- Currently receiving lithium or neuroleptics

- Hospitalization with the last 5 years for depression, or clinical judgment of treatment for major depression

- Hearing or sight impairments

- Cognitive impairment

- Alcohol consumption greater than 21 drinks per week, or self-reported alcoholism

- Inability to speak or read English

- Judgment of clinical staff

- Current participation in another medical intervention study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
Prosocial Behavior Physical Activity (PBPA)
The PBPA condition involves a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9. PBPA participants also earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity.
Physical Exercise (PE)
The PE condition is a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9.

Locations

Country Name City State
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. — View Citation

Rejeski WJ, Brawley LR, Ambrosius WT, Brubaker PH, Focht BC, Foy CG, Fox LD. Older adults with chronic disease: benefits of group-mediated counseling in the promotion of physically active lifestyles. Health Psychol. 2003 Jul;22(4):414-23. — View Citation

Rejeski WJ, Foy CG, Brawley LR, Brubaker PH, Focht BC, Norris JL 3rd, Smith ML. Older adults in cardiac rehabilitation: a new strategy for enhancing physical function. Med Sci Sports Exerc. 2002 Nov;34(11):1705-13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported physical activity Baseline, 3 and 9 months No
Secondary Physical function, health-related quality of life Baseline, 3 and 9 months No
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