Health-Related Quality of LifeNCT00747019
Prosocial Behavior and Exercise Among Older Adults
A study testing Prosocial Behavior Physical Activity (PBPA) and Physical Exercise (PE) in people with Health-Related Quality of Life and Physical Activity, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-Related Quality of Life, Physical Activity, Physical Function
- What is being tested?
- Prosocial Behavior Physical Activity (PBPA) and Physical Exercise (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27127
Carol Massa-Fanale, 336-716-3589, cmassa@wfubmc.edu
Susan J. Harris, 336-713-4244, sjharris@wfubmc.edu
About this study
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.
Read the detailed 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.
- Being tested
- Prosocial Behavior Physical Activity (PBPA), Physical Exercise (PE)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosocial Behavior Physical Activity (PBPA)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PBPA | Experimental | Not described Receives: Behavioral: Prosocial Behavior Physical Activity (PBPA) |
| PE | Active comparator | Not described Receives: Behavioral: Physical Exercise (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical activity
Measured: Baseline, 3 and 9 months
Secondary outcomes (1)
Physical function, health-related quality of life
Measured: Baseline, 3 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health-Related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Capri G. Foy, PhD, MS, Principal investigator, Division of Public Health Sciences, Wake Forest University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747019
- Sponsor's protocol ID
- AG0106
- Other IDs
- 1R21AG027413-01A2
- Status last verified
- Jun 2009
- First submitted
- 3 Sep 2008
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12940398Rejeski 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.
PubMed 12439072Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. No abstract available.
PubMed 3562705
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosocial Behavior and Exercise Among Older Adults
- ClinicalTrials.gov ID
- NCT00747019
- Acronym / sponsor ID
- AG0106
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBPA | Experimental | Behavioral: Prosocial Behavior Physical Activity (PBPA) |
| PE | Active comparator | Behavioral: Physical Exercise (PE) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
- 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:
- Hearing or sight impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PBPA |
| 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. | Behavioural | PE |
Primary outcome
Self-reported physical activity
Time frame: Baseline, 3 and 9 months
1 secondary outcome
Physical function, health-related quality of life
Time frame: Baseline, 3 and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Background: PubMed 12940398Rejeski 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.
- Background: PubMed 12439072Rejeski 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.
- Background: PubMed 3562705Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capri G. Foy, PhD, MS principal investigator
Division of Public Health Sciences, Wake Forest University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosocial Behavior Physical Activity (PBPA) and Physical Exercise (PE) in people with Health-Related Quality of Life and Physical Activity, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Massa-Fanale, MS (336-716-3589, cmassa@wfubmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity (time frame: Baseline, 3 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747019, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.