Life 2: Improving Fitness and Function in Elders (Project LIFE)
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
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
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Usual Gait Speed
Lasso di tempo: Baseline
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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
|
|
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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
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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
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical Activity Frequency (CHAMPS Questionnaire)
Lasso di tempo: Baseline
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Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
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Baseline
|
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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
|
|
Self Rated Health
Lasso di tempo: Baseline
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Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
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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
|
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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
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12 month
|
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Sf-36 Physical Function Subscale
Lasso di tempo: Baseline
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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.
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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
|
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2 Minute Walk
Lasso di tempo: Baseline
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Distance walked in two minutes in meters
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Baseline
|
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2 Minute Walk
Lasso di tempo: 3 month
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Distance walked in two minutes in meters
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3 month
|
|
2 Minute Walk
Lasso di tempo: 12 month
|
Distance walked in two minutes in meters
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12 month
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Miriam C. Morey, PhD, VA Medical Center
Pubblicazioni e link utili
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.
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Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
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 .