Prevention Harmful EffectsNCT02909374
"Stay Balanced" - Prevention of Falls in Older Adults - From Clinical Research to Clinical Practice
A study testing Balance training in people with Prevention Harmful Effects, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years or older, independent ambulatory indoors, self-perceived balance problems and/or fear of falling.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet
Stockholm
Alexandra Halvarsson, med dr, alexandra.halvarsson@ki.se
About this study
Official title: "Stay Balanced" - Prevention of Falls in Older Adults Through Implementation of Evidence Based Balance Training - From Clinical Research to Clinical Practice
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.
Read more
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.
Read the detailed description
This project is a cluster-randomized study comparing different implementation strategies. The study will comprise clinical settings in primary health care (PHC) and in senior residential care.
Participating clinics will be recruited strategically with regard to catchment area and population structure, to achieve such a large diverse participation as possible.
Participant to the balance training will be recruited through the participating clinics, from primary care facilities in the vicinity of the clinics involved and by advertisement in local papers in the communities. Participants reporting their interest to partake in the study will be telephone-interview and informed about the project and checked for eligibility. Thereafter, they will be called to baseline testing.
The investigators plan to involve 30 different PHC and thereby 360-480 participants in balance training (two groups with 6-8 participants per semester from each clinic during 2 semesters).
In two previous randomised controlled studies performed by the research group in Stockholm county regarding group balance-training for older adults at risk of falling the investigators received a large number of people reporting interest by announcement, i.e. approximately 500 subjects. However, most of them were excluded because they had not a verified diagnosis of osteoporosis, which was one of the inclusion criteria's in those two studies.
The group based balance-training program is well described in a published ´Rehabilitation in practice´- article and 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, i.e. performance when a person's attention is divided between a motor and a cognitive task, as this is a natural component of daily activities, but may increase the risk of falling especially in older adults. As training adaptions are specific for the system trained, this program follows the principle of specificity in that it is based on exercises targeting various systems for postural control aiming to improve balance performance in specific situations that can occur in daily life, such as regaining postural stability after perturbation or being able to suddenly avoid an obstacle, with retained balance, while simultaneously walking and answering a question. Furthermore, 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. 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".
For the implementation a participatory approach will be used, where the different settings will be engaged in an early phase. For evaluation the model by Proctor et al., will be followed. The implementation strategies will include 1) a contract with each setting, 2) meetings with the head of each setting, 3) discussion with physical therapists and leaders in the setting, 4) education of the physical therapists and leaders who will be trainers and 5) coaching of the trainers.
Implementation outcomes will include:
- Acceptability of evidence-based treatments among health providers will be assessed by investigating the attitudes towards the balance program with a questionnaire, focus groups and interviews.
- Feasibility the extent to which a new treatment can be successfully used and carried out in the clinical setting will be assessed by investigating how the balance program fits in in clinical practice with focus groups and interviews.
- Fidelity includes five dimensions, i.e. adherence to the program protocol, quality of delivery, program component differentiation, exposure to the intervention and participant responsiveness to the program will be investigated by observations, check-lists and assessments on individual level (see below).
- Cost will be assessed by a health economic evaluation of the program.
- Sustainability will be assessed using both quantitative and qualitative methods and include measures on compliance/fidelity to the training program.
Assessments on individual level will include fall-related concerns, health related quality of life, balance performance, gait, physical activity, muscle strength for lower extremities and number of falls and compliance to training.
The assessments on individual level will be performed at the PHC by the regular physiotherapist. All participants will be assessed before and after the training period (3 months after inclusion) and at three to six, twelve eight-teen and twenty-four months, i.e. two years after inclusion. During the follow-up period, i.e. three, six, twelve, eight-teen and twenty-four months, the assessments will consists of sms-track system and by postal survey with questionnaire regarding fall-related concerns, heath related quality of life, physical activity and adherence to training regime.
- Conditions
- Prevention Harmful Effects
- Being tested
- Balance training
- Keywords
- Implementation, fall prevention, balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Sustainability will be assessed during a period of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start1 Jan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention Harmful EffectsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Halvarsson, Karolinska Institutet
- Investigators
- Alexandra Halvarsson, med.dr, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909374
- Sponsor's protocol ID
- Dnr 2016/415-31
- Status last verified
- Sep 2020
- First submitted
- 6 Apr 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33637122
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Stay Balanced" - Prevention of Falls in Older Adults Through Implementation of Evidence Based Balance Training - From Clinical Research to Clinical Practice
- ClinicalTrials.gov ID
- NCT02909374
- Acronym / sponsor ID
- Dnr 2016/415-31
- Conditions
- Prevention Harmful Effects
- Keywords
- Implementation, fall prevention, balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project is a cluster-randomized study comparing different implementation strategies. The study will comprise clinical settings in primary health care (PHC) and in senior residential care.
Participating clinics will be recruited strategically with regard to catchment area and population structure, to achieve such a large diverse participation as possible.
Participant to the balance training will be recruited through the participating clinics, from primary care facilities in the vicinity of the clinics involved and by advertisement in local papers in the communities. Participants reporting their interest to partake in the study will be telephone-interview and informed about the project and checked for eligibility. Thereafter, they will be called to baseline testing.
The investigators plan to involve 30 different PHC and thereby 360-480 participants in balance training (two groups with 6-8 participants per semester from each clinic during 2 semesters).
In two previous randomised controlled studies performed by the research group in Stockholm county regarding group balance-training for older adults at risk of falling the investigators received a large number of people reporting interest by announcement, i.e. approximately 500 subjects. However, most of them were excluded because they had not a verified diagnosis of osteoporosis, which was one of the inclusion criteria's in those two studies.
The group based balance-training program is well described in a published ´Rehabilitation in practice´- article and 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, i.e. performance when a person's attention is divided between a motor and a cognitive task, as this is a natural component of daily activities, but may increase the risk of falling especially in older adults. As training adaptions are specific for the system trained, this program follows the principle of specificity in that it is based on exercises targeting various systems for postural control aiming to improve balance performance in specific situations that can occur in daily life, such as regaining postural stability after perturbation or being able to suddenly avoid an obstacle, with retained balance, while simultaneously walking and answering a question. Furthermore, 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. 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".
For the implementation a participatory approach will be used, where the different settings will be engaged in an early phase. For evaluation the model by Proctor et al., will be followed. The implementation strategies will include 1) a contract with each setting, 2) meetings with the head of each setting, 3) discussion with physical therapists and leaders in the setting, 4) education of the physical therapists and leaders who will be trainers and 5) coaching of the trainers.
Implementation outcomes will include:
- Acceptability of evidence-based treatments among health providers will be assessed by investigating the attitudes towards the balance program with a questionnaire, focus groups and interviews.
- Feasibility the extent to which a new treatment can be successfully used and carried out in the clinical setting will be assessed by investigating how the balance program fits in in clinical practice with focus groups and interviews.
- Fidelity includes five dimensions, i.e. adherence to the program protocol, quality of delivery, program component differentiation, exposure to the intervention and participant responsiveness to the program will be investigated by observations, check-lists and assessments on individual level (see below).
- Cost will be assessed by a health economic evaluation of the program.
- Sustainability will be assessed using both quantitative and qualitative methods and include measures on compliance/fidelity to the training program.
Assessments on individual level will include fall-related concerns, health related quality of life, balance performance, gait, physical activity, muscle strength for lower extremities and number of falls and compliance to training.
The assessments on individual level will be performed at the PHC by the regular physiotherapist. All participants will be assessed before and after the training period (3 months after inclusion) and at three to six, twelve eight-teen and twenty-four months, i.e. two years after inclusion. During the follow-up period, i.e. three, six, twelve, eight-teen and twenty-four months, the assessments will consists of sms-track system and by postal survey with questionnaire regarding fall-related concerns, heath related quality of life, physical activity and adherence to training regime.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Balance trainingThe 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". |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years or older, independent ambulatory indoors, self-perceived balance problems and/or fear of falling.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance trainingThe 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. | Other | Balance training |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 33637122Halvarsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Halvarsson, med.dr principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Prevention Harmful Effects, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Halvarsson, med. dr (+46852488810, alexandra.halvarsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustainability of the balance training programme in clinical setting (time frame: Sustainability will be assessed during a period of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.