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

NCT02909374 | Unknown

• 1 other identifier: Dnr 2016/415-31
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention Harmful Effects

Keywords

Implementation; fall prevention; balance training

Outcome Measures

Primary Outcomes (1)

• Sustainability of the balance training programme in clinical setting

  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

  Sustainability will be assessed during a period of 18 months

Study Arms (1)

Balance training

EXPERIMENTAL

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

Interventions

Balance training OTHER

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.

Balance training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

• Halvarsson A, Roaldsen KS, Nilsen P, Dohrn IM, Stahle A. StayBalanced: implementation of evidence-based fall prevention balance training for older adults-cluster randomized controlled and hybrid type 3 trial. Trials. 2021 Feb 26;22(1):166. doi: 10.1186/s13063-021-05091-1.

  PMID: 33637122 DERIVED

Study Officials

• Alexandra Halvarsson, med.dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Halvarsson, med. dr

CONTACT

+46852488810; alexandra.halvarsson@ki.se

Agneta Ståhle, professor

CONTACT

+46852488810; agneta.stahle@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medicine doctor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

SE (1)