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.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Alfara Del Patriarca, Spanien, 46113
- Vicent Benavent Caballer
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Exercise
Multi-modal exercise program
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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.
|
|
Experimentell: Exercise plus nutritional suplementation
Multi-modal exercise program plus nutritional suplementation
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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.
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Inget ingripande: Control
No interventions
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Timed up and go test
Tidsram: 5-10 minutes
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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.
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5-10 minutes
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- University CEU-UCH
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