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Life 2: Improving Fitness and Function in Elders (Project LIFE)

8 januari 2015 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

400

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • VA Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

70 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Arm 2
Vanlig skötsel
Experimentell: 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
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Usual Gait Speed
Tidsram: Baseline
Best of two trials over 8-foot walk
Baseline
Usual Gait Speed
Tidsram: 3 month
3 month
Usual Gait Speed
Tidsram: 12-month
12-month
Rapid Gait Speed
Tidsram: Baseline
Baseline
Rapid Gait Speed
Tidsram: 3-month
3-month
Rapid Gait Speed
Tidsram: 12-month
12-month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical Activity Frequency (CHAMPS Questionnaire)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Baseline
Self Rated Health
Tidsram: 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
Tidsram: 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
Tidsram: 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
Sf-36 Physical Function Subscale
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
Distance walked in two minutes in meters
Baseline
2 Minute Walk
Tidsram: 3 month
Distance walked in two minutes in meters
3 month
2 Minute Walk
Tidsram: 12 month
Distance walked in two minutes in meters
12 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Miriam C. Morey, PhD, VA Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2004

Primärt slutförande (Faktisk)

1 april 2008

Avslutad studie (Faktisk)

1 april 2008

Studieregistreringsdatum

Först inskickad

12 februari 2007

Först inskickad som uppfyllde QC-kriterierna

13 februari 2007

Första postat (Uppskatta)

14 februari 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 januari 2015

Senast verifierad

1 januari 2015

Mer information

Termer relaterade till denna studie

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