- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00435188
Life 2: Improving Fitness and Function in Elders (Project LIFE)
8. januar 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- VA Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
70 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Arm 2
Sædvanlig pleje
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Usual Gait Speed
Tidsramme: Baseline
|
Best of two trials over 8-foot walk
|
Baseline
|
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Usual Gait Speed
Tidsramme: 3 month
|
3 month
|
|
|
Usual Gait Speed
Tidsramme: 12-month
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12-month
|
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Rapid Gait Speed
Tidsramme: Baseline
|
Baseline
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Rapid Gait Speed
Tidsramme: 3-month
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3-month
|
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Rapid Gait Speed
Tidsramme: 12-month
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12-month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity Frequency (CHAMPS Questionnaire)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 month
|
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
|
12 month
|
|
Sf-36 Physical Function Subscale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Distance walked in two minutes in meters
|
Baseline
|
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2 Minute Walk
Tidsramme: 3 month
|
Distance walked in two minutes in meters
|
3 month
|
|
2 Minute Walk
Tidsramme: 12 month
|
Distance walked in two minutes in meters
|
12 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Miriam C. Morey, PhD, VA Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2004
Primær færdiggørelse (Faktiske)
1. april 2008
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
12. februar 2007
Først indsendt, der opfyldte QC-kriterier
13. februar 2007
Først opslået (Skøn)
14. februar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E3386-R
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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