Clinical trial NCT03320668: Efficacy of the Otago Exercise Program Delivered as Group Training Versus Individually Tailored Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Problem
Keywords: Falls Prevention
Otago Program
Community-Dwelling
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: Fondo de Investigacion Sanitaria
name: Osakidetza
name: MurciaSalud
First posted: 2017-10-25
Enrollment: 878
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority clinical trial, multicentric, simple blind
Primary purpose: PREVENTION

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.

Detailed description: OBJECTIVES:

To compare the effectiveness of the Otago Exercise Program (OEP) delivered as group training versus individually tailored training in community-dwelling adults between 65 and 80 years old, on the probability of falls, improved functional balance and muscle strength and, quality of walk in the 12 months follow up.

To compare the effectiveness of both interventions to improve dynamic and static balance and gait quality in the same population.

DESIGN:

Non-inferiority clinical trial, multicentric, simple blind (blind analysis to prevent bias), with two interventions, implementation of group and individual OEP with random assign. The follow-up period will be twelve months after the OEP training.

FIELD OF STUDY:

21 Primary Health Centers (PHC) belonging to the National Health System in 8 different regions: Andalucía, Asturias, Islas Baleares, Canarias, Cataluña, Comunidad de Madrid, Región de Murcia and País Vasco

PARTICIPANTS:

Subjects who belong to primary care centers in the same health area, 65 to 80 years of age, who are not institutionalized, independent for walk (the score of the first part of the Short Physical Performance Battery scale (SPPB scale) in relation to balancing must be different from zero in any assessed position) and provide informed consent to participate in the study.

VARIABLES OF STUDY:

Principal Outcome: Percentage of falls (percentage of subjects falling)

Other Outcomes:

Safety of Intervention; Feasibility of interventions; Feasibility of the cascade training model based on the OEP; Economic analysis and added therapeutic value of both interventions.

DATA COLLECTION:

Subjects will be selected from the health centers through active recruitment by the health professionals.

The recruitment will be consecutive among the patients in the agenda in the days between 10 to 19 of each month from September 2017-December 2018.

Data will be collected at month 0, 6 and 12. Randomization will be performed by PHC and by subjects.

DATA ANALYSIS:

A descriptive analysis of sociodemographic and fall variables will be performed. The analysis to the comparative data between the two groups of the Randomize Clinical Trial will be done by protocol. In addition, an analysis will be made for the incidence density of falls, using Poisson regression models. For all a confidence level of 95% will be assumed, and the statistical software to be used to carry out the analysis will be Statistical Package for the Social Sciences version 22 (SPSS v22).

Eligibility 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)

Primary outcomes:
measure: Percentage of falls
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
measure: Adherence
timeFrame: 12 months
measure: Participant satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Osakidetza
state: Araba Kalea, 45, Vitoria-Gasteiz
city: Córdoba
country: Spain
facility: Universidad de Córdoba
state: Av. De Medina Azahara, 5
city: Madrid
country: Spain
facility: Servicio de Salud de Madrid
state: Avenida Abrantes, 55
city: Palmas de Gran Canaria
country: Spain
facility: Servicio de Salud de Canarias
state: Avenida Juan Xxiii,17
city: Murcia
country: Spain
facility: Servicio Murciano de Salud
state: Calle Central, 7, Espinardo
city: Palma de Mallorca
country: Spain
facility: Servei de Salut de Les Illes Balears
state: Carrer De La Reina Esclaramunda, 9, Palma
city: Barcelona
country: Spain
facility: Institut Català de la Salut (ICS)
state: Gran Via De Les Corts Catalanes, 587-589
city: Barcelona
country: Spain
facility: Institut Català de la Salut
state: Gran Via De Les Corts Catalanes, 587-589
city: Oviedo
country: Spain
facility: Servicio de Salud del Principado de Asturias
state: Plaza Del Carbayón, Oviedo
Study officials:
affiliation: Instituto de Salud Carlos III
name: Teresa Moreno-Cascas, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.