NCT03958318

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

The Effectiveness of a Multi-component Exercise Program Plus Oral Nutritional Supplementation, on the Functional Capacity in Frail Institutionalized Older Adults.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Cardenal Herrera University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fragility

Interventions

Type	Name	Description
OTHER	Exercise plus nutritional suplementation	For 6 months, all participants in the exercise plus nutritional supplementation group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.
OTHER	Exercise	For 6 months, all participants in the exercise group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.

Timeline

• Start date: 2019-05-30
• Primary completion: 2019-12-03
• Completion: 2019-12-22
• First posted: 2019-05-22
• Last updated: 2020-01-27

Locations

1 site across 1 country: Spain