- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00747019
Prosocial Behavior and Exercise Among Older Adults
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27127
- Reclutamento
- Wake Forest University School of Medicine
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Contatto:
- Susan J. Harris
- Numero di telefono: 336-713-4244
- Email: sjharris@wfubmc.edu
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Contatto:
- Carol Massa-Fanale
- Numero di telefono: 336-716-3589
- Email: cmassa@wfubmc.edu
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Investigatore principale:
- Capri G. Foy, PhD, MS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: PBPA
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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.
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Comparatore attivo: PE
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Self-reported physical activity
Lasso di tempo: Baseline, 3 and 9 months
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Baseline, 3 and 9 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Physical function, health-related quality of life
Lasso di tempo: Baseline, 3 and 9 months
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Baseline, 3 and 9 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Capri G. Foy, PhD, MS, Division of Public Health Sciences, Wake Forest University School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. No abstract available.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- AG0106
- 1R21AG027413-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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