Recruiting

Observational Study

Sponsor:

National Institute on Aging (NIA)

Code:

NCT00747019

Conditions

Health-Related Quality of Life

Physical Activity

Physical Function

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

Prosocial Behavior Physical Activity (PBPA)

Physical Exercise (PE)

Study Details

Brief 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.

Conditions

Health-Related Quality of Life

Physical Activity

Physical Function

Study ID

NCT00747019

Start date

Dec, 2008

Status verified date

Jun, 2009

Completion date

Jun, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PBPA

active comparator: PE

Interventions

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.

Primary outcome measure

  • Self-reported physical activity [ Time Frame: Baseline, 3 and 9 months ]

Central Contacts and Locations

Central contacts

Carol Massa-Fanale, MS

336-716-3589cmassa@wfubmc.edu

Susan J. Harris

336-713-4244sjharris@wfubmc.edu

Locations

Wake Forest University School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27127

Contacts

Carol Massa-Fanale

336-716-3589cmassa@wfubmc.edu

Susan J. Harris

336-713-4244sjharris@wfubmc.edu

Principal Investigator:

Capri G. Foy, PhD, MS

More Information

Sponsor

National Institute on Aging (NIA)

Last update posted

Jul 2, 2009

Last verified

Jun, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute on Aging (NIA) on 2009-07-02.