Performance EnhancementNCT05551000
Functional vs Traditional Training in Older Women's Health
A study of Performance Enhancement, run by Aalborg University at 1 site in Norway.
Trial summary
This study investigates how balance, mobility, strength, gait speed, and health-related quality of life in older adults (65+) are affected after an 8-week training period using the Norwegian national concept for older adults, Strong and Steady, compared to a modified version that incorporates functional training… Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2023to 22 Dec 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderlies aged 65 to 75 years old.
- Have been participating and physical training for at least six months before the start of the intervention.
- The participants must be highly motivated for the project, which will be measured using the likard scale.
Who cannot join
- Illness or injury within the last three months.
- Do not have the ability to complete the test battery concerning set minimum criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional vs Traditional Group-Based Training in Community-Dwelling Older Women: A Cluster Randomized Controlled Trial
This study investigates how balance, mobility, strength, gait speed, and health-related quality of life in older adults (65+) are affected after an 8-week training period using the Norwegian national concept for older adults, Strong and Steady, compared to a modified version that incorporates functional training variables.
- Conditions
- Performance Enhancement
- Being tested
- Experimental, comparator and control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental, comparator and controlOther
To quantify the effect of a training intervention for elderlies on improved range of motion, dynamic balance, gait speed, gait coordination, everyday movements and strength compared to a training group from the Norwegian elderly concept "Stærk og Stødig" and a control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will use a functional training system developed specifically for elderlies to improve everyday movements, physical strength and balance. Receives: Other: Experimental, comparator and control |
| Positive control | Active comparator | This group will use a general training system developed for elderlies to improve everyday movements, physical strength and balance. Receives: Other: Experimental, comparator and control |
| Negative control | No intervention | Control group: A group that is not treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-Balance Test
Measure balance performance (Cm)
Measured: Day 1
Y-Balance Test
Measure balance performance (Cm)
Measured: 2 months
Secondary outcomes (10)
SF-36 questionnaire
Measure the participant's Health-related quality of life
Measured: 2 months
Mobility test
Chair-sit-and-reach and back scratch test (Cm)
Measured: 2 months
Mobility test
Chair-sit-and-reach and back scratch test (Cm)
Measured: Day 1
SF-36 questionnaire
Measure the participant's Health-related quality of life
Measured: 1 day
6-minute walking test
Measure walking distance (Meters)
Measured: 2 months
6-minute walking test
Measure walking distance (Meters)
Measured: Day 1
Time up-and-go test
Measure agility (Secounds)
Measured: 2 months
Time up-and-go test
Measure agility (Secounds)
Measured: Day 1
Functional Strength Test
Chair stand and Arm curl test (Repetitions)
Measured: 2 months
Strength Test
Chair stand and Arm curl test (Repetitions)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Oct 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance EnhancementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Lasse Engberg Treu Lassen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551000
- Sponsor's protocol ID
- 438956
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2022
- Last updated
- 4 Mar 2026
- Results posted
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional vs Traditional Group-Based Training in Community-Dwelling Older Women: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05551000
- Acronym / sponsor ID
- 438956
- Conditions
- Performance Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 22 Sep 2022 (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 investigates how balance, mobility, strength, gait speed, and health-related quality of life in older adults (65+) are affected after an 8-week training period using the Norwegian national concept for older adults, Strong and Steady, compared to a modified version that incorporates functional training variables.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Experimental, comparator and controlThis group will use a functional training system developed specifically for elderlies to improve everyday movements, physical strength and balance. |
| Positive control | Active comparator | Other: Experimental, comparator and controlThis group will use a general training system developed for elderlies to improve everyday movements, physical strength and balance. |
| Negative control | No intervention | –Control group: A group that is not treated. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderlies aged 65 to 75 years old.
- Have been participating and physical training for at least six months before the start of the intervention.
- The participants must be highly motivated for the project, which will be measured using the likard scale.
Key exclusion criteria (2 listed)
- Illness or injury within the last three months.
- Do not have the ability to complete the test battery concerning set minimum criteria
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 |
|---|---|---|
| Experimental, comparator and controlTo quantify the effect of a training intervention for elderlies on improved range of motion, dynamic balance, gait speed, gait coordination, everyday movements and strength compared to a training group from the Norwegian elderly concept "Stærk og Stødig" and a control group. | Other | Intervention, Positive control |
Primary outcome
Y-Balance Test
Time frame: Day 1
Measure balance performance (Cm)
Y-Balance Test
Time frame: 2 months
Measure balance performance (Cm)
10 secondary outcomes
SF-36 questionnaire
Time frame: 2 months
Mobility test
Time frame: 2 months
Mobility test
Time frame: Day 1
SF-36 questionnaire
Time frame: 1 day
6-minute walking test
Time frame: 2 months
6-minute walking test
Time frame: Day 1
Time up-and-go test
Time frame: 2 months
Time up-and-go test
Time frame: Day 1
Functional Strength Test
Time frame: 2 months
Strength Test
Time frame: Day 1
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 4 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Performance Enhancement, run by Aalborg University at 1 site in Norway.
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 3 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: finished, as of the sponsor's last update on 4 Mar 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 Norway. 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?
Y-Balance Test (time frame: Day 1). The study lists 2 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 4 Mar 2026.