Accidental FallsNCT06774508
Feasibility of High-intensity Functional Exercise With Simultaneous Cognitive Challenge for Older People With Falls Risk
A study testing HIFE+cog and HIFE in people with Accidental Falls and Postural Balance, run by Umeå University at 1 site in Sweden.
Trial summary
This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Accidental Falls, Postural Balance, Gait
- What is being tested?
- HIFE+cog and HIFE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 17 Feb 2025to 1 Sep 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 75 years or older
- moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG >15 s without walking aid)
- can walk independently indoors, without a walking aid
- can walk 500m independently outdoors, with or without a walking aid
Who cannot join
- a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)
- Mini-Mental State Examination (MMSE) score <24 or dementia diagnosis
- a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of a High-intensity Functional Exercise Program With Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People With Intermediate Risk for Falls: a Randomized Controlled Pilot Trial
This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims:
- To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences.
- To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.
The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.
- Conditions
- Accidental Falls, Postural Balance, Gait, Cognition
- Being tested
- HIFE+cog, HIFE
- Keywords
- Accidental falls, Postural balance, Gait, Cognition, Exercise therapy, Resistance training, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFE+cogOther
Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Simultaneous cognitive exercises are added to static and dynamic balance exercises. Relative exercise intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.
HIFEOther
Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Relative exercises intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity functional exercise with cognitive challenge (HIFE+Cog) | Experimental | High intensity functional exercise (HIFE+Cog) program with simultaneous cognitive challenge, individually tailored and performed twice weekly for 12 weeks, in supervised groups. Receives: Other: HIFE+cog |
| High-intensity functional exercise (HIFE) | Active comparator | High intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups. Receives: Other: HIFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Rate of recruited participants, and sources for recruitment
Measured: Before intervention start
Adherence
Number of exercise sessions attended
Measured: Through the 3-month intervention
Exercise intervention content and delivery
Number of exercises, sets, repetitions, and intensity achieved measured using a standardized exercise diary completed by supervisors after each session
Measured: Through the 3-month intervention
Retention
Number of participants that completed follow-ups
Measured: Through the 3-month intervention
Safety
Adverse events, including falls and discomfort reported during or between sessions by participants or supervisors, and measured using a standardized exercise diary completed by supervisors after each session
Measured: Through the 3-month intervention period
Balance and gait capacity
The Timed up and go (TUG) test, with and without cognitive task
Measured: Baseline, 3 months
Balance and gait capacity
The 4m forward gait speed test, with and without cognitive task
Measured: Baseline, 3 months
Balance and gait capacity
The 4m backward gait speed test
Measured: Baseline, 3 months
Balance and gait capacity
The Berg balance scale
Measured: Baseline, 3 months
Balance and gait capacity
The 30-s Chair stand test
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Mental speed with The Reaction test I and II
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Attention and executive function (shifting) with The Trail making test - Click (TMT-Click)
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Short term- and working memory with The Corsi Block test
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Executive function (inhibition) with The Stroop test
Measured: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test
Measured: Baseline, 3 months
Occupational performance
The Canadian Occupational Performance Measure (COPM)
Measured: Baseline, 3 months
Experiences of the intervention and effects
Individual interviews with participants in the intervention group
Measured: 3 months
Secondary outcomes (7)
Fear of falling
The Falls Self-Efficacy Scale (FES-I)
Measured: Baseline, 3 months
Psychological wellbeing
The Philadelphia Geriatric Center Morale Scale (PGCMS)
Measured: Baseline, 3 months
Physical activity
The International Physical Activity Questionnaire-Elderly (IPAQ-E)
Measured: Baseline, 3 months
Depressive disorders
The Geriatric Depression Scale (GDS-15)
Measured: Baseline, 3 months
Health related quality of life
The EQ5D, Selected questions from The short form (36) Health survey
Measured: Baseline, 3 months
Activities of daily life (ADL)
The Katz ADL Index
Measured: Baseline, 3 months
Descriptive information
Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start17 Feb 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Principal investigator, Annika Toots, Umeå University
- Investigators
- Annika Toots, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774508
- Sponsor's protocol ID
- Dnr 2024-07683-01
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analysed during the study will not publicly available to protect the participants' confidentiality (in accordance with The General Data Protection Regulation, European Union Regulation) but are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a High-intensity Functional Exercise Program With Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People With Intermediate Risk for Falls: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06774508
- Acronym / sponsor ID
- Dnr 2024-07683-01
- Conditions
- Accidental Falls, Postural Balance, Gait, Cognition
- Keywords
- Accidental falls, Postural balance, Gait, Cognition, Exercise therapy, Resistance training, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Jan 2025 (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.
This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims:
- To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences.
- To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.
The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity functional exercise with cognitive challenge (HIFE+Cog) | Experimental | Other: HIFE+cogHigh intensity functional exercise (HIFE+Cog) program with simultaneous cognitive challenge, individually tailored and performed twice weekly for 12 weeks, in supervised groups. |
| High-intensity functional exercise (HIFE) | Active comparator | Other: HIFEHigh intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 75 years or older
- moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG >15 s without walking aid)
- can walk independently indoors, without a walking aid
- can walk 500m independently outdoors, with or without a walking aid
Key exclusion criteria (3 listed)
- a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)
- Mini-Mental State Examination (MMSE) score <24 or dementia diagnosis
- a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)
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 |
|---|---|---|
| HIFE+cogEach session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Simultaneous cognitive exercises are added to static and dynamic balance exercises. Relative exercise intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up. | Other | High-intensity functional exercise with cognitive challenge (HIFE+Cog) |
| HIFEEach session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Relative exercises intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up. | Other | High-intensity functional exercise (HIFE) |
Primary outcome
Recruitment
Time frame: Before intervention start
Rate of recruited participants, and sources for recruitment
Adherence
Time frame: Through the 3-month intervention
Number of exercise sessions attended
Exercise intervention content and delivery
Time frame: Through the 3-month intervention
Number of exercises, sets, repetitions, and intensity achieved measured using a standardized exercise diary completed by supervisors after each session
Retention
Time frame: Through the 3-month intervention
Number of participants that completed follow-ups
Safety
Time frame: Through the 3-month intervention period
Adverse events, including falls and discomfort reported during or between sessions by participants or supervisors, and measured using a standardized exercise diary completed by supervisors after each session
Balance and gait capacity
Time frame: Baseline, 3 months
The Timed up and go (TUG) test, with and without cognitive task
Balance and gait capacity
Time frame: Baseline, 3 months
The 4m forward gait speed test, with and without cognitive task
Balance and gait capacity
Time frame: Baseline, 3 months
The 4m backward gait speed test
Balance and gait capacity
Time frame: Baseline, 3 months
The Berg balance scale
Balance and gait capacity
Time frame: Baseline, 3 months
The 30-s Chair stand test
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Mental speed with The Reaction test I and II
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Attention and executive function (shifting) with The Trail making test - Click (TMT-Click)
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Short term- and working memory with The Corsi Block test
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Executive function (inhibition) with The Stroop test
Cognitive function
Time frame: Baseline, 3 months
The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test
Occupational performance
Time frame: Baseline, 3 months
The Canadian Occupational Performance Measure (COPM)
Experiences of the intervention and effects
Time frame: 3 months
Individual interviews with participants in the intervention group
7 secondary outcomes
Fear of falling
Time frame: Baseline, 3 months
Psychological wellbeing
Time frame: Baseline, 3 months
Physical activity
Time frame: Baseline, 3 months
Depressive disorders
Time frame: Baseline, 3 months
Health related quality of life
Time frame: Baseline, 3 months
Activities of daily life (ADL)
Time frame: Baseline, 3 months
Descriptive information
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. The datasets generated and analysed during the study will not publicly available to protect the participants' confidentiality (in accordance with The General Data Protection Regulation, European Union Regulation) but are available from the principal investigator on reasonable request.
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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.
Annika Toots, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFE+cog and HIFE in people with Accidental Falls and Postural Balance, run by Umeå University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment (time frame: Before intervention start). The study lists 18 primary outcomes in all. 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 9 Oct 2026.