Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of the Otago Exercise Program Delivered as Group Training Versus Individually Tailored Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320668
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Osakidetza
MurciaSalud
Information provided by (Responsible Party):
Teresa Moreno Casbas, Instituto de Salud Carlos III

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.

Condition or disease Intervention/treatment Phase
Age Problem Other: Otago Exercise Program (OEP) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority clinical trial, multicentric, simple blind
Masking: Single (Outcomes Assessor)
Masking Description: Blind analysis to prevent bias
Primary Purpose: Prevention
Official Title: Efficacy of the Otago Exercise Program (OEP) Delivered as Group Training Versus Individually Tailored Training in Community-dwelling Adults Between 65 and 80 Years Old
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Individual OEP

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.

Experimental: Group OEP
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)
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.
Other Name: Usual Practice




Primary Outcome Measures :
  1. Percentage of falls [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    1. Adverse events during the intervention related to exclusion criteria (indication for a subject to leave the project)
    2. Adverse effects which can be directly or potentially associated with Otago exercises. For that, it will be established an external committee which will classify the adverse event among related, potentially related and none related with Otago exercise execution.

  2. Adherence [ Time Frame: 12 months ]

    Adherence level to exercise program will be measured following the Exercise Adherence Rating Scale (EARS) through self-declared falls diary.

    The EARS questionnaire is composed of 6 items, each of them is scaled from 0 (minimum) to 4 (maximum score). Total score is the sum of the 6 items, so that it ranges from a minimum score of 0 and a maximum score of 64.

    Adherence measurements will be collected at 6 and 12 months.


  3. Participant satisfaction [ Time Frame: 12 months ]

    Participant satisfaction with the intervention will be measured through "ad hoc" survey which include the following items:

    4.1. Received information about exercise program and its benefits 4.2. Received Training about Otago Exercise Program 4.3. Assessment of Material 4.4. Teaching skills of your OEP trainer 4.5. Receptiveness of your health care professional to solve your doubts about the OEP 4.6. Global satisfaction with Otago Exercise Program

    Each item will be scaled from 0 (Totally unsatisfied) to 4 (Very satisfied).

    Total minimum and maximum scores are 0 and 64, respectively.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320668


Locations
Layout table for location information
Spain
Osakidetza
Vitoria, Araba Kalea, 45, Vitoria-Gasteiz, Spain, 01006
Universidad de Córdoba
Córdoba, Av. De Medina Azahara, 5, Spain, 14005
Servicio de Salud de Madrid
Madrid, Avenida Abrantes, 55, Spain, 28025
Servicio de Salud de Canarias
Palmas de Gran Canaria, Avenida Juan Xxiii,17, Spain, 35071
Servicio Murciano de Salud
Murcia, Calle Central, 7, Espinardo, Spain, 30100
Servei de Salut de Les Illes Balears
Palma de Mallorca, Carrer De La Reina Esclaramunda, 9, Palma, Spain, 07003
Institut Català de la Salut (ICS)
Barcelona, Gran Via De Les Corts Catalanes, 587-589, Spain, 08004
Institut Català de la Salut
Barcelona, Gran Via De Les Corts Catalanes, 587-589, Spain, 08004
Servicio de Salud del Principado de Asturias
Oviedo, Plaza Del Carbayón, Oviedo, Spain, 33001
Sponsors and Collaborators
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Osakidetza
MurciaSalud
Investigators
Layout table for investigator information
Study Director: Teresa Moreno-Cascas, Doctor Instituto de Salud Carlos III

Layout table for additonal information
Responsible Party: Teresa Moreno Casbas, Unit Director, Instituto de Salud Carlos III
ClinicalTrials.gov Identifier: NCT03320668    
Other Study ID Numbers: PI16CIII/00031
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Moreno Casbas, Instituto de Salud Carlos III:
Falls Prevention
Otago Program
Community-Dwelling