Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults

Not Applicable

Completed

• Conditions: Fragility
• Interventions: Other: Exercise; Other: Exercise plus nutritional suplementation

• Registration Number: NCT03958318
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Study Start: 2019-05-30
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Multi-modal exercise program
Exercise plus nutritional suplementation	Exercise plus nutritional suplementation	Multi-modal exercise program plus nutritional suplementation

Primary Outcome Measures

Name	Time	Method
Timed up and go test	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.

Trial Locations

Locations (1)

Vicent Benavent Caballer; 🇪🇸 Alfara Del Patriarca, Spain