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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Alfara Del Patriarca, Spanje, 46113
- Vicent Benavent Caballer
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Experimenteel: 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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Geen tussenkomst: Control
No interventions
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Timed up and go test
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- University CEU-UCH
Informatie over medicijnen en apparaten, studiedocumenten
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