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

Fragility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958318
• Other study ID #: University CEU-UCH
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: December 22, 2019

Study information

• Verified date: January 2020
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 22, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fragility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Vicent Benavent Caballer	Alfara Del Patriarca

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go test	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.	5-10 minutes