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

8 januari 2015 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27705
        • VA Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

70 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Arm 2
Gebruikelijke zorg
Experimenteel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Usual Gait Speed
Tijdsspanne: Baseline
Best of two trials over 8-foot walk
Baseline
Usual Gait Speed
Tijdsspanne: 3 month
3 month
Usual Gait Speed
Tijdsspanne: 12-month
12-month
Rapid Gait Speed
Tijdsspanne: Baseline
Baseline
Rapid Gait Speed
Tijdsspanne: 3-month
3-month
Rapid Gait Speed
Tijdsspanne: 12-month
12-month

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical Activity Frequency (CHAMPS Questionnaire)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Baseline
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Baseline
Self Rated Health
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Distance walked in two minutes in meters
Baseline
2 Minute Walk
Tijdsspanne: 3 month
Distance walked in two minutes in meters
3 month
2 Minute Walk
Tijdsspanne: 12 month
Distance walked in two minutes in meters
12 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2004

Primaire voltooiing (Werkelijk)

1 april 2008

Studie voltooiing (Werkelijk)

1 april 2008

Studieregistratiedata

Eerst ingediend

12 februari 2007

Eerst ingediend dat voldeed aan de QC-criteria

13 februari 2007

Eerst geplaatst (Schatting)

14 februari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

9 januari 2015

Laatste update ingediend die voldeed aan QC-criteria

8 januari 2015

Laatst geverifieerd

1 januari 2015

Meer informatie

Termen gerelateerd aan deze studie

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