Efficacy of the Otago Exercise Program Delivered as Group Training Versus Individually Tailored Training
NCT03320668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 878
Last updated 2022-08-03
Summary
A non-inferiority controlled clinical trial using randomization for allocation at the level of general practice in 21 centers (in 8 Spanish regions), to compare a group Otago exercise program (OEP) \[delivered by specifically trained instructors and supplemented by prescriptive recommendations for home exercising\], with an individual OEP \[also delivered by specifically trained professionals and supplemented by prescriptive recommendations for home exercising\], with twelve months follow-up to determine the effectiveness of the OEP in terms of prevention of falls in a community-dwelling 65- to 80-year-old population.
Conditions
- Age Problem
Interventions
- OTHER
-
Otago Exercise Program (OEP)
A nurse/physiotherapist supported by an "instructor"-trained professional will give Otago Exercise Program (OEP) education to 10-people groups in 5 sessions (1st, 2nd, 4th and 8th week and one reinforcement session after 6 months). Telephone calls to participants will be made during non-training months (following a predefined telephonic interview protocol) to follow up. The OEP reduces the number of falls and fall-related injuries, improving balance and strength, confidence in performing everyday activities without falling. Whilst it has been shown to be effective in 4 controlled trials in New Zealand, it has not been tested in a primary care setting in Spain for feasibility, impact, acceptability and cost-effectiveness.
Sponsors & Collaborators
-
Fondo de Investigacion Sanitaria
collaborator OTHER -
Osakidetza
collaborator OTHER -
MurciaSalud
collaborator OTHER_GOV -
Instituto de Salud Carlos III
lead OTHER_GOV
Principal Investigators
-
Teresa Moreno-Cascas, Doctor · Instituto de Salud Carlos III
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-10
- Primary Completion
- 2021-12-30
- Completion
- 2022-02-28
Countries
- Spain
Study Locations
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