NCT02617303

Brief Summary

Falls are an important risk factor for fragility fractures. Both are associated with the ageing process and as they rise also increase the risk of mortality, disability and dependency. Interventions to prevent falls have been based on multifactorial approaches but the outcomes have shown little effectiveness. Lately, it is being recommended interventions which foster physical exercise incorporating it to daily life activities. The OTAGO exercise programme is based on easy physical exercises for older adults and has shown cost-effective outcomes for falls prevention and its consequences.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

June 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 22, 2021

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

June 11, 2015

Last Update Submit

June 21, 2021

Conditions

Accidental FallsOsteoporosis

Keywords

elderlyaccidental fallsosteoporosisfracturesPrimary CareRandomized clinical trialOtago exercise programme

Outcome Measures

Primary Outcomes (1)

  • Reduction of falls measured with a questionnaire from April 2016 to June 2017.

    Evaluate the incidence of OTAGO's physical intervention program on fall reduction in elderly (75-89years). Starting training with phase guided by physiotherapist, followed by loyalty phase guided by regular nurse. It will be measured with a questionnaire at baseline and during follow-up.

    15 months

Secondary Outcomes (9)

  • Reduction of fracture measured with a questionnaire (location, causes and consequences) from April 2016 to June 2017.

    15 months

  • Reduction of fear to fall measured with Falls Efficacy Scale (FES) from April 2016 to June 2017.

    15 months

  • Parameters of physical frailty (strength) measured with switched test Timed Get Up and Go (TGUAG) from April 2016 to June 2017.

    15 months

  • Parameters of physical frailty (balance) measured through Biodex Balance System ('stability index') from April 2016 to June 2017.

    15 months

  • Parameters of physical frailty (motion) measured through "BTS G-WALK" from April 2016 to June 2017.

    15 months

  • +4 more secondary outcomes

Study Arms (2)

OTAGO'S program arm

EXPERIMENTAL

Patients meeting the inclusion criteria will be randomly assigned to the experimental group. They will receive OTAGO'S exercise program during three months, followed by adherence phase. Falls and fractures will be quarterly followed during 15 months.

Procedure: OTAGO's exercises

CONTROL GROUP

ACTIVE COMPARATOR

Patients meeting the inclusion criteria will be randomly assigned to the control group. Normal medical treatment will be provided by family physicians and nurses. Falls and fractures will be quarterly followed during 15 months.

Procedure: COMMON PRACTICE

Interventions

OTAGO's exercisesPROCEDURE

The intervention is based on OTAGO's program, consisting of a set of aerobic exercises affecting gait, balance, stability and are adapted for older people to support them both in groups and individually. The program lasts 6 weeks (2 sessions per week) and is followed by a loyalty phase to consolidate the exercise program. Falls and fractures will be monitored quarterly for 15 months.

OTAGO'S program arm
COMMON PRACTICEPROCEDURE

Normal medical treatment will be provided by family physicians and nurses.

CONTROL GROUP

Eligibility Criteria

Age75 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients ≥ 75 to 89 years at baseline assigned to Primary Care Team and living in the community
  • Ranking the Folstein Mini Mental State Examination test
  • Expectation of permanence in the area at least 18 months.
  • Agree to participate in the study by informed consent, after reading the patient information sheet.

You may not qualify if:

  • Current participation in another trial or institutional program of guided physical activity.
  • Patients with who have had a hip and/or knee operation or major injury or any other intervention in the last 6 months.
  • Patients with who are unable to follow an aerobic physical activity program. Patients using assisted mobility devices are not excluded.
  • Patients in Home Care Programs or Nursing Homes at baseline or during the training phase.
  • Terminal or severe cancer cases.
  • Patients disabled prior to or during the study period.
  • Have not been visited in reference's Health Center in the last two years (displacement / transfer
  • Very advanced dementia that not allows to follow the instructions in the exercise program and nurse's instructions. In case of a caregiver who assume the realization of exercise program and the following of tips, it may be included.
  • Displaced, will temporarily shifted (\>2months/year) o will definitively shifted patients of Health Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CAP Barberà del Vallès

Barbera Del Valles, Barcelona, 08210, Spain

Location

CAP Canaletes

Cerdanyola del Vallès, Barcelona, 08290, Spain

Location

CAP Serraparera

Cerdanyola del Vallès, Barcelona, 08290, Spain

Location

CAP Creu Alta

Sabadell, Barcelona, 08208, Spain

Location

CAP Badia del Vallés

Barcelona, 08214, Spain

Location

CAP Castellar

Castellar del Vallès, 08211, Spain

Location

CAP La Llagosta

La Llagosta, 08120, Spain

Location

Cap Centre

Sabadell, 08201, Spain

Location

Cap Can Rull

Sabadell, 08206, Spain

Location

CAP Ca N'Oriach

Sabadell, 08207, Spain

Location

CAP Sud

Sabadell, Spain

Location

MeSH Terms

Conditions

OsteoporosisFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Rafael Azagra, PhD

    Insitut Català de la Salut, Universitat Autònoma de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

November 30, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

December 1, 2021

Last Updated

June 22, 2021

Record last verified: 2020-10

Locations

ES(11)