Quality of LifeBETANCT03464825
Prevention of Falls in Older Adults by Specific and Progressive Balance Training
A study testing Specific and progressive balance training in people with Quality of Life, run by Karolinska Institutet.
Trial summary
Three months of balance training with follow-up 6 and 12 months thereafter. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Specific and progressive balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 60 years with either osteoporosis or Parkinsons disease
Who cannot join
- under 60 years
About this study
Three months of balance training with follow-up 6 and 12 months thereafter.
- Conditions
- Quality of Life
- Being tested
- Specific and progressive balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific and progressive balance trainingOther
Specific and progressive balance training for the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Participants in the intervention group receive balance training during 3 months 3 times per week Receives: Other: Specific and progressive balance training |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance performance - one leg stand
One leg stand during 30 seconds
Measured: up to 24 months
Secondary outcomes (2)
Fear of falling FES-I
Questionnaire measuring fear of falling
Measured: up to 24 months
Health related quality of life - SF-36
Questionnaire measuring health related quality of life
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Jan 2010
- Primary completion1 Jan 2018
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- One intervention group receiving Specific and progressive balance training One control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Stahle, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464825
- Sponsor's protocol ID
- K2011-69P-20908-02-4
- Acronym
- BETA
- Status last verified
- Mar 2018
- First submitted
- 3 Mar 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Falls in Older Adults by Specific and Progressive Balance Training
- ClinicalTrials.gov ID
- NCT03464825
- Acronym / sponsor ID
- BETA / K2011-69P-20908-02-4
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 14 Mar 2018 (actual)
- 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.
Three months of balance training with follow-up 6 and 12 months thereafter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- One intervention group receiving Specific and progressive balance training One control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Specific and progressive balance trainingParticipants in the intervention group receive balance training during 3 months 3 times per week |
| Control | No intervention | –Care as usual |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 60 years with either osteoporosis or Parkinsons disease
Key exclusion criteria (1 listed)
- under 60 years
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 |
|---|---|---|
| Specific and progressive balance trainingSpecific and progressive balance training for the intervention group | Other | Intervention |
Primary outcome
Balance performance - one leg stand
Time frame: up to 24 months
One leg stand during 30 seconds
2 secondary outcomes
Fear of falling FES-I
Time frame: up to 24 months
Health related quality of life - SF-36
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Specific and progressive balance training in people with Quality of Life, run by Karolinska Institutet.
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 1 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance - one leg stand (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2018.