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

C

Cardenal Herrera University

Status

Completed

Conditions

Fragility

Treatments

Other: Exercise plus nutritional suplementation
Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03958318
University CEU-UCH

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 3 patient groups

Exercise
Experimental group
Description:
Multi-modal exercise program
Treatment:
Other: Exercise
Exercise plus nutritional suplementation
Experimental group
Description:
Multi-modal exercise program plus nutritional suplementation
Treatment:
Other: Exercise plus nutritional suplementation
Control
No Intervention group
Description:
No interventions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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