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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03958318

Enrollment

110

Registered

2019-05-22

Start date

2019-05-30

Completion date

2019-12-22

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragility

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.

Interventions

OTHERExercise 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.

OTHERExercise

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026