The Effectiveness of a Multi-component Exercise Program Plus Oral Nutritional Supplementation, on the Functional Capacity in Frail Institutionalized Older Adults.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fragility
- Sponsor
- Cardenal Herrera University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Timed up and go test
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this study is to evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance in frail institutionalized older adults.
Participants will be randomly allocated to the intervention groups; exercise (EG) or exercise plus nutritional supplementation (SG), or to the control group (CG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.
Detailed Description
Objectives: Evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance and the capacity to perform daily tasks in frail institutionalized older adults. Design: Randomized controlled trial, with a 6-month intervention period. Participants: 122 frail institutionalized older adults aged 65 and older with no cognitive impairment. Intervention: After a baseline assessment, the participants will be randomly assigned to the control group or one of two intervention groups; multi-modal exercise program (EG) or exercise plus nutritional supplementation (SG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement. Measurements: The primary outcome measure will be mobility measured with the timed up and go test. Secondary outcomes will be the functional balance, hand-grip strength, lower limb functional capacity, gait speed and distance covered during the 6-minute walk test.
Investigators
Juan F. Lisón Párraga, Dr
Head of Medicine
Cardenal Herrera University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 65 years;
- •Frail institutionalized.
Exclusion Criteria
- •Cognitive impairment;
- •Fracture;
- •Neurological disorder;
- •Unable to follow verbal instructions;
- •Score lower than 60 in the Barthel Index.
Outcomes
Primary Outcomes
Timed up and go test
Time Frame: 5-10 minutes
The participants will be instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials will be performed, and the quicker time in seconds will be recorded.