NCT03320668

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

5 years

First QC Date

October 20, 2017

Last Update Submit

August 2, 2022

Conditions

Age Problem

Keywords

Falls PreventionOtago ProgramCommunity-Dwelling

Outcome Measures

Primary Outcomes (1)

  • Percentage of falls

    The participant will be provided with a notebook which should be completed each month. In the case a fall occur, the patient will be asked to fill the following items regarding the fall characteristics: Data, place, context in which the fall happened, consequences and attention required.

    12 months

Secondary Outcomes (3)

  • Adverse events

    12 months

  • Adherence

    12 months

  • Participant satisfaction

    12 months

Study Arms (2)

Individual OEP

NO INTERVENTION

Randomized subjects (65 to 80-year-old) receiving individual Otago Exercise Program (OEP) training in a total of nine Primary Care Centers. An "OEP leader" trained nurse/physiotherapist will perform in its community consult individual education to each participant in five sessions: In the 1st, 2nd, 4th and 8th week and one reinforcement session after six months. A telephone call to each participant (following a predefined telephonic interview protocol) will be carried out in the months without training session to perform the follow-up.

Group OEP

EXPERIMENTAL

65-80 year-old randomized subjects receiving group Otago Exercise Program (OEP) training in a total of nine Primary Care Centers.

Other: Otago Exercise Program (OEP)

Interventions

Otago Exercise Program (OEP)OTHER

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.

Also known as: Usual Practice
Group OEP

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects who belong (ascribed) to primary healthcare centers of the same health area, aged 65 to 80 years, non-institutionalized, independents for ambulation (the scores achieved from the first part of SPPB scale in relation of the balance will be different from zero in any position evaluated.) and provide their informed consent for participating in the study.

You may not qualify if:

  • Subject such residential period in the Health Basic Area of the primary health center or it life expectancies has lower 9 months. in the health area of the primary healthcare center.
  • Mild and moderate cognitive impairment (according to the diagnosis from medical history).
  • Sight-impairment or hearing impairment which prevent to follow the intervention (according to the diagnosis from medical history).
  • Absolute contraindication to perform physical exercise (according to the diagnosis from medical history)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Osakidetza

Vitoria-Gasteiz, Araba Kalea, 45, Vitoria-Gasteiz, 01006, Spain

Location

Universidad de Córdoba

Córdoba, Av. de Medina Azahara, 5, 14005, Spain

Location

Servicio de Salud de Madrid

Madrid, Avenida Abrantes, 55, 28025, Spain

Location

Servicio de Salud de Canarias

Las Palmas de Gran Canaria, Avenida Juan Xxiii,17, 35071, Spain

Location

Servicio Murciano de Salud

Murcia, Calle Central, 7, Espinardo, 30100, Spain

Location

Servei de Salut de Les Illes Balears

Palma de Mallorca, Carrer de La Reina Esclaramunda, 9, Palma, 07003, Spain

Location

Institut Català de la Salut (ICS)

Barcelona, Gran Via de Les Corts Catalanes, 587-589, 08004, Spain

Location

Institut Català de la Salut

Barcelona, Gran Via de Les Corts Catalanes, 587-589, 08004, Spain

Location

Servicio de Salud del Principado de Asturias

Oviedo, Plaza Del Carbayón, Oviedo, 33001, Spain

Location

Related Publications (2)

  • Albornos-Munoz L, Blanco-Blanco J, Cidoncha-Moreno MA, Abad-Corpa E, Rivera-Alvarez A, Lopez-Pisa RM, Caperos JM; Otago Project Working Group Consortium; Moreno-Casbas MT. Efficacy of the Otago-Exercise-Programme to reduce falls in community-dwelling adults aged 65-80 when delivered as group or individual training: Non-inferiority-clinical-trial. BMC Nurs. 2024 Oct 1;23(1):705. doi: 10.1186/s12912-024-02310-3.

    PMID: 39354514DERIVED

  • Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.

    PMID: 34999543DERIVED

Study Officials

  • Teresa Moreno-Cascas, Doctor

    Instituto de Salud Carlos III

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blind analysis to prevent bias
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-inferiority clinical trial, multicentric, simple blind
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Unit Director

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 25, 2017

Study Start

January 10, 2017

Primary Completion

December 30, 2021

Study Completion

February 28, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(9)