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Prevention of Falls in Older Adults by Specific and Progressive Balance Training (BETA)

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: NCT03464825
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Agneta Stahle, Karolinska Institutet

Brief Summary:
Three months of balance training with follow-up 6 and 12 months thereafter.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Specific and progressive balance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One intervention group receiving Specific and progressive balance training One control group
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Falls in Older Adults by Specific and Progressive Balance Training
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Intervention
Participants in the intervention group receive balance training during 3 months 3 times per week
Other: Specific and progressive balance training
Specific and progressive balance training for the intervention group

No Intervention: Control
Care as usual



Primary Outcome Measures :
  1. Balance performance - one leg stand [ Time Frame: up to 24 months ]
    One leg stand during 30 seconds


Secondary Outcome Measures :
  1. Fear of falling FES-I [ Time Frame: up to 24 months ]
    Questionnaire measuring fear of falling

  2. Health related quality of life - SF-36 [ Time Frame: up to 24 months ]
    Questionnaire measuring health related quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 60 years with either osteoporosis or Parkinsons disease

Exclusion Criteria:

  • under 60 years

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Responsible Party: Agneta Stahle, professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03464825    
Other Study ID Numbers: K2011‐69P‐20908‐02‐4
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No