Efficacy of the Otago Exercise Program Delivered as Group Training Versus Individually Tailored Training
Condition: Age Problem
Study type: Interventional

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).
    

Intervention name(s): Otago Exercise Program (OEP)
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Usual Practice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-inferiority clinical trial, multicentric, simple blind
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Falls Prevention; Otago Program; Community-Dwelling