- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00435188
Life 2: Improving Fitness and Function in Elders (Project LIFE)
8 gennaio 2015 aggiornato da: US Department of Veterans Affairs
The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans.
The primary physical performance outcome is change in gait speed.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability.
Rates of physical inactivity are highest among older adults.
Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function.
Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations.
The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed.
Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life.
We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA.
Design.
Randomized controlled clinical trial.
Data collection.
All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year.
The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality.
Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals.
Differences between groups for non-routine outpatient clinic use and hospitalization will be explored.
The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups.
Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components.
We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy.
Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs.
Duration Four years.
Relevance to the VA.
Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
400
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- VA Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
70 anni e precedenti (Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Age 70 or over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
Exclusion Criteria:
- Age 70 or over
- Followed in VA primary care or geriatrics clinic
- Currently not regularly physically active
- Able to walk 10 meters without human assistance (assistive device acceptable)
- A terminal diagnosis
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Braccio 2
Solita cura
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Sperimentale: Arm 1
Behavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
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A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Usual Gait Speed
Lasso di tempo: Baseline
|
Best of two trials over 8-foot walk
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Baseline
|
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Usual Gait Speed
Lasso di tempo: 3 month
|
3 month
|
|
|
Usual Gait Speed
Lasso di tempo: 12-month
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12-month
|
|
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Rapid Gait Speed
Lasso di tempo: Baseline
|
Baseline
|
|
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Rapid Gait Speed
Lasso di tempo: 3-month
|
3-month
|
|
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Rapid Gait Speed
Lasso di tempo: 12-month
|
12-month
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical Activity Frequency (CHAMPS Questionnaire)
Lasso di tempo: Baseline
|
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
|
Baseline
|
|
Physical Activity Frequency (CHAMPS Questionnaire)
Lasso di tempo: 3 month
|
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
|
3 month
|
|
Physical Activity Frequency (CHAMPS Questionnaire)
Lasso di tempo: 12 month
|
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
|
12 month
|
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Self Rated Health
Lasso di tempo: Baseline
|
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
|
Baseline
|
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Self Rated Health
Lasso di tempo: 3 month
|
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
|
3 month
|
|
Self Rated Health
Lasso di tempo: 12 month
|
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
|
12 month
|
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Sf-36 Physical Function Subscale
Lasso di tempo: Baseline
|
This is a subscale of the SF-36 Medical Outcomes Study.
The Physical Function subscale assesses a self-reported ability to perform physical tasks.
It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
|
Baseline
|
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Sf-36 Physical Function Subscale
Lasso di tempo: 3 month
|
This is a subscale of the SF-36 Medical Outcomes Study.
The Physical Function subscale assesses a self-reported ability to perform physical tasks.
It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
|
3 month
|
|
Sf-36 Physical Function Subscale
Lasso di tempo: 12 month
|
This is a subscale of the SF-36 Medical Outcomes Study.
The Physical Function subscale assesses a self-reported ability to perform physical tasks.
It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
|
12 month
|
|
2 Minute Walk
Lasso di tempo: Baseline
|
Distance walked in two minutes in meters
|
Baseline
|
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2 Minute Walk
Lasso di tempo: 3 month
|
Distance walked in two minutes in meters
|
3 month
|
|
2 Minute Walk
Lasso di tempo: 12 month
|
Distance walked in two minutes in meters
|
12 month
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Miriam C. Morey, PhD, VA Medical Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
- Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
- Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper P, McConnell E, Bosworth H, Ekelund C, Pearson M, Howard T. Project LIFE--Learning to Improve Fitness and Function in Elders: methods, design, and baseline characteristics of randomized trial. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044.
- Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Pearson MP. The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men. J Am Geriatr Soc. 2009 Jul;57(7):1166-74. doi: 10.1111/j.1532-5415.2009.02301.x. Epub 2009 May 8.
- Hall KS, Crowley GM, McConnell ES, Bosworth HB, Sloane R, Ekelund CC, Morey MC. Change in goal ratings as a mediating variable between self-efficacy and physical activity in older men. Ann Behav Med. 2010 Jun;39(3):267-73. doi: 10.1007/s12160-010-9177-5.
- Huffman KM, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention. Scand J Rheumatol. 2010 May;39(3):233-9. doi: 10.3109/03009740903348973.
- Huffman KM, Hall KS, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis? Scand J Rheumatol. 2010;39(5):380-6. doi: 10.3109/03009741003605630.
- Hall KS, Crowley GM, Bosworth HB, Howard TA, Morey MC. Individual progress toward self-selected goals among older adults enrolled in a physical activity counseling intervention. J Aging Phys Act. 2010 Oct;18(4):439-50. doi: 10.1123/japa.18.4.439.
- Hall KS, Sloane R, Pieper CF, Peterson MJ, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Morey MC. Long-term changes in physical activity following a one-year home-based physical activity counseling program in older adults with multiple morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407.
- Lum H, Sloane R, Huffman KM, Kraus VB, Thompson DK, Kraus WE, Bain JR, Stevens R, Pieper CF, Taylor GA, Newgard CB, Cohen HJ, Morey MC. Plasma acylcarnitines are associated with physical performance in elderly men. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2004
Completamento primario (Effettivo)
1 aprile 2008
Completamento dello studio (Effettivo)
1 aprile 2008
Date di iscrizione allo studio
Primo inviato
12 febbraio 2007
Primo inviato che soddisfa i criteri di controllo qualità
13 febbraio 2007
Primo Inserito (Stima)
14 febbraio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
9 gennaio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 gennaio 2015
Ultimo verificato
1 gennaio 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E3386-R
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 .