- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00435188
Life 2: Improving Fitness and Function in Elders (Project LIFE)
8 janvier 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
400
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- VA Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
70 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Bras 2
Soins habituels
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Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Usual Gait Speed
Délai: Baseline
|
Best of two trials over 8-foot walk
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Baseline
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Usual Gait Speed
Délai: 3 month
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3 month
|
|
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Usual Gait Speed
Délai: 12-month
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12-month
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Rapid Gait Speed
Délai: Baseline
|
Baseline
|
|
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Rapid Gait Speed
Délai: 3-month
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3-month
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Rapid Gait Speed
Délai: 12-month
|
12-month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical Activity Frequency (CHAMPS Questionnaire)
Délai: 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)
Délai: 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)
Délai: 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
|
12 month
|
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Self Rated Health
Délai: 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
Délai: 3 month
|
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
Délai: 12 month
|
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
|
12 month
|
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Sf-36 Physical Function Subscale
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
|
Distance walked in two minutes in meters
|
Baseline
|
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2 Minute Walk
Délai: 3 month
|
Distance walked in two minutes in meters
|
3 month
|
|
2 Minute Walk
Délai: 12 month
|
Distance walked in two minutes in meters
|
12 month
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Miriam C. Morey, PhD, VA Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2004
Achèvement primaire (Réel)
1 avril 2008
Achèvement de l'étude (Réel)
1 avril 2008
Dates d'inscription aux études
Première soumission
12 février 2007
Première soumission répondant aux critères de contrôle qualité
13 février 2007
Première publication (Estimation)
14 février 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 janvier 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 janvier 2015
Dernière vérification
1 janvier 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E3386-R
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