Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03958318
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.
Study:
NCT03958318
Study Brief:
Protocol Section:
NCT03958318