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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320668 on ClinicalTrials.gov