NCT00747019

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 2, 2009

Status Verified

June 1, 2009

Enrollment Period

1.5 years

First QC Date

September 3, 2008

Last Update Submit

June 30, 2009

Conditions

Health-Related Quality of LifePhysical ActivityPhysical Function

Outcome Measures

Primary Outcomes (1)

  • Self-reported physical activity

    Baseline, 3 and 9 months

Secondary Outcomes (1)

  • Physical function, health-related quality of life

    Baseline, 3 and 9 months

Study Arms (2)

PBPA

EXPERIMENTAL
Behavioral: Prosocial Behavior Physical Activity (PBPA)

PE

ACTIVE COMPARATOR
Behavioral: Physical Exercise (PE)

Interventions

Prosocial Behavior Physical Activity (PBPA)BEHAVIORAL

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.

PBPA
Physical Exercise (PE)BEHAVIORAL

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.

PE

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27127, United States

RECRUITING

Related Publications (3)

  • 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. doi: 10.1037/0278-6133.22.4.414.

    PMID: 12940398BACKGROUND

  • 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. doi: 10.1097/00005768-200211000-00003.

    PMID: 12439072BACKGROUND

  • Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. No abstract available.

    PMID: 3562705BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Capri G. Foy, PhD, MS

    Division of Public Health Sciences, Wake Forest University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Massa-Fanale, MS

CONTACT

336-716-3589cmassa@wfubmc.edu

Susan J. Harris

CONTACT

336-713-4244sjharris@wfubmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

December 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 2, 2009

Record last verified: 2009-06

Locations

US(1)