Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- University of Colorado Anschutz Medical Campus
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
|
|
|
Aucune intervention: Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in physical activity as determined by accelerometer
Délai: 12 weeks
|
Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
|
12 weeks
|
|
Changes in physical function as assessed by 400-meter walk speed
Délai: 12 weeks
|
Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
|
12 weeks
|
|
Changes in physical function as assessed by Short Physical Performance Battery
Délai: 12 weeks
|
Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
|
12 weeks
|
|
Change in physical function as assessed by lower extremity strength testing
Délai: 12 weeks
|
Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluation of standard implementation science process of reach
Délai: 1 year
|
Reach is the percent of patients consented divided by the number eligible.
|
1 year
|
|
Assessment of standard implementation science process metrics of acceptability
Délai: 1 year
|
Acceptability will be assessed through structured surveys.
|
1 year
|
|
Assessment of standard implementation science process metrics of implementation
Délai: 1 year
|
Implementation process will be assessed by structured surveys
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amy Huebschmann, MD, University of Colorado - Anschutz Medical Campus
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .