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"Stay Balanced" - Prevention of Falls in Older Adults - From Clinical Research to Clinical Practice

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ClinicalTrials.gov Identifier: NCT02909374
Recruitment Status : Not yet recruiting
First Posted : September 21, 2016
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandra Halvarsson, Karolinska Institutet

Brief Summary:

Fall is one of the most common causes of ill health and morbidity in the older population. In Sweden about 300 000 people/year seek emergency treatment due to falls and out of these 1600 dies. Poor balance control leads to a sedentary life with muscle weakness, fear of falling and an increased risk for falls. Balance training and physical activity have positive effects on fall prevention and balance, but long-term follow-ups are limited. There is also a gap between what has been proven to be efficient in research and what is performed in communities and clinical settings.

Many studies reports on the efficacy of certain treatment, method or training program, which often may have taken years to develop, but few of these results are taken further into clinical practice and it may take years for them to come into daily use. This delay means that there is a gap between what is known and what is consistently done. It if of importance implement methods that have been proven to have beneficial impact on health and physical function in a clinical trial. Furthermore to evaluate which strategies for implementation that are of significance. The aim of this study is to implement evidence based balance training into clinical practice to prevent future falls and fall-related injuries in older adults.

The program has been proven to be efficient, but not yet been implemented in the community and clinical settings. Implementation outcomes will include effectiveness, acceptability, feasibility, fidelity, cost and sustainability. Outcome variables on individual level will be fall-related concerns, balance performance, physical function and activity, health related quality of life and number of falls.

The investigators foresee that this balance training for older adults will prevent future falls and fall related injuries, increase physical activity level, health related quality of life and provide the participants with a strategy to be able to have a physically active and healthy life style.


Condition or disease Intervention/treatment Phase
Prevention Harmful Effects Other: Balance training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: "Stay Balanced" - Prevention of Falls in Older Adults Through Implementation of Evidence Based Balance Training - From Clinical Research to Clinical Practice
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Balance training
The program includes exercise with dual- and multi task performance and is progressive as the exercises can be performed at different levels (basic, moderate, and advanced). The 12-week balance training program will be performed two times per week for one hour each. The training will be lead by physiotherapists or trained leaders. After the balance training the participants will get recommendations for continued physical activity and training, i.e. "Physical activity on prescription".
Other: Balance training
The balance-training program was developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task. It includes exercise with dual- and multi task performance. It is progressive as the exercises can be performed at different levels (basic, moderate, and advanced), making it progressively challenging for each individual throughout the whole program. The training is conducted as an individually tailored group program.




Primary Outcome Measures :
  1. Sustainability of the balance training programme in clinical setting [ Time Frame: Sustainability will be assessed during a period of 18 months ]
    Sustainability will be assessed using both quantitative and qualitative methods and include measures on compliance/fidelity to the training program. A successful implementation will be consider if the clinic has contained/sustained the balance training during 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 years or older, independent ambulatory indoors, self-perceived balance problems and/or fear of falling.

Exclusion Criteria:

  • Had fall-related fractures during the last six months,
  • Severely decreased vision, or other diseases or constrains that might interfere with participation in the training program.

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): NCT02909374


Contacts
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Contact: Alexandra Halvarsson, med. dr +46852488810 alexandra.halvarsson@ki.se
Contact: Agneta Ståhle, professor +46852488810 agneta.stahle@ki.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden
Contact: Alexandra Halvarsson, med dr       alexandra.halvarsson@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Alexandra Halvarsson, med.dr Karolinska Institutet

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Responsible Party: Alexandra Halvarsson, medicine doctor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02909374     History of Changes
Other Study ID Numbers: Dnr 2016/415-31
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandra Halvarsson, Karolinska Institutet:
Implementation
fall prevention
balance training