- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00435188
Life 2: Improving Fitness and Function in Elders (Project LIFE)
8. ledna 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
400
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27705
- VA Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
70 let a starší (Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Rameno 2
Obvyklá péče
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Usual Gait Speed
Časové okno: 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
Časové okno: 3 month
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3 month
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Usual Gait Speed
Časové okno: 12-month
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12-month
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Rapid Gait Speed
Časové okno: Baseline
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Baseline
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Rapid Gait Speed
Časové okno: 3-month
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3-month
|
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Rapid Gait Speed
Časové okno: 12-month
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12-month
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Physical Activity Frequency (CHAMPS Questionnaire)
Časové okno: 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
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Baseline
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Physical Activity Frequency (CHAMPS Questionnaire)
Časové okno: 3 month
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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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3 month
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Physical Activity Frequency (CHAMPS Questionnaire)
Časové okno: 12 month
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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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12 month
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Self Rated Health
Časové okno: 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
Časové okno: 3 month
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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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3 month
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Self Rated Health
Časové okno: 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
Časové okno: 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.
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Baseline
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Sf-36 Physical Function Subscale
Časové okno: 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
|
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Sf-36 Physical Function Subscale
Časové okno: 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
Časové okno: Baseline
|
Distance walked in two minutes in meters
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Baseline
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2 Minute Walk
Časové okno: 3 month
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Distance walked in two minutes in meters
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3 month
|
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2 Minute Walk
Časové okno: 12 month
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Distance walked in two minutes in meters
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12 month
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Miriam C. Morey, PhD, VA Medical Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2004
Primární dokončení (Aktuální)
1. dubna 2008
Dokončení studie (Aktuální)
1. dubna 2008
Termíny zápisu do studia
První předloženo
12. února 2007
První předloženo, které splnilo kritéria kontroly kvality
13. února 2007
První zveřejněno (Odhad)
14. února 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
9. ledna 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. ledna 2015
Naposledy ověřeno
1. ledna 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E3386-R
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .