AgedNCT04127539
Evaluation of Strong & Steady - Fall Preventive Group Exercise Program
A study testing Strong & Steady exercise program in people with Aged, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the study is to investigate the effect of Strong and Steady (S\&S) group exercise on fall risk and physical function among community-dwelling older adults over 12 months. A pre-post test study deign will be used. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Strong & Steady exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteNorway
- Study dates
- 14 Sep 2020to 20 Dec 2021
- 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
- Able to get to the training facilities on their own
- Able to walk without a walking aid indoors
Who cannot join
- Diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Strong & Steady: A Group Exercise Program for Preventing Functional Decline and Falls Among Community Dwelling Older Adults
The aim of the study is to investigate the effect of Strong and Steady (S\&S) group exercise on fall risk and physical function among community-dwelling older adults over 12 months. A pre-post test study deign will be used.
Read the detailed description
The S\&S group exercise program builds on the Otago and FaME exercise programs which have shown to be effective in preventing falls. Strong and steady has been adapted to more functionally fit older people.
The study period will be one year. Due to the corona pandemic all S\&S groups in Norway have been closed. Due to this all participants have had a break from their exercise program for more than 6 months and can be seen av new participants to the exercise groups. Participants that are about to start in a S\&S group in municipalities in Trøndelag will be asked to participate in this study. They will go through tests of muscle strength and balance in addition to questionnaires at baseline and after 6 and 12 months of exercise. Where possible the participants will go through the same tests 1 month before they start to exercise in addition to the three other test timepoints.
- Conditions
- Aged
- Being tested
- Strong & Steady exercise program
- Keywords
- Exercise, Fall prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong & Steady exercise programBehavioural
The community-based group exercise program S\&S, with strengthening and balance exercise as the main components. The participants will attend a once-weekly, one hour supervised session. The exercises that will be used can be found in the S\&S handbook which includes different difficulty levels. All instructors are volunteers and have completed the S\&S education. Each exercise session will consist of a warm-up (5-8 min.), endurance exercises (10-15 min.), strength exercises (15 min.), balance exercises (20 min.) and a cool down/stretching (5 min.). In addition to attending the group exercises, the participants will be taught and encouraged to do home exercises twice a week from hand out leaflets that can be found at www.sterkogstodig.no.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will start a Strong \& Steady group exercise programme immediately after baseline testing. Receives: Behavioral: Strong & Steady exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 sec chair rise
Change in number of stands from a chair managed within a time frame of 30 seconds.
Measured: Baseline and 3 months
Secondary outcomes (6)
Short Physical Performance Battery total score
Includes 5x Sit-to-stand, 4 meters walk test and 3 different 10 sec stance positions. Change in total score (0-12 points).
Measured: Baseline, 3, 6 and 12 months
Number of falls
Number of falls will be collected by daily calendars collected every month
Measured: 12 months
The Short Falls Efficacy Scale-International
The Short Falls Efficacy Scale-International (Short FES-I) questionnaire will be used to assess fear of falling. The total score range from 7 (no concern about falling) to 28 (severe concern about falling). Change in total score will be assessed.
Measured: Baseline, 3, 6 and 12 months
Everyday physical activity
Axivity activity sensors fixed to the lower back ang thigh will be used to measure everyday physical activity. Change in time spent doing physical activity will be assessed.
Measured: One week monitoring at baseline, 3, 6 and 12 months
30 sec chair rise
Change in number of stands from a chair managed within a time frame of 30 seconds.
Measured: Baseline, 6 and 12 months
Four square step test
Time spent doing a sequence of moving through four squares back and fourth.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start14 Sep 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Glasgow Caledonian University, Fysiofondet
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, PhD/Prof, Study director, The Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127539
- Sponsor's protocol ID
- 2019/255
- Status last verified
- Mar 2022
- First submitted
- 14 Oct 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be fully anonymised 5 years after study completion and made available for other researcher by request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Strong & Steady: A Group Exercise Program for Preventing Functional Decline and Falls Among Community Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04127539
- Acronym / sponsor ID
- 2019/255
- Conditions
- Aged
- Keywords
- Exercise, Fall prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Glasgow Caledonian University, Fysiofondet
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 15 Oct 2019 (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.
The aim of the study is to investigate the effect of Strong and Steady (S\&S) group exercise on fall risk and physical function among community-dwelling older adults over 12 months. A pre-post test study deign will be used.
Detailed description
The S\&S group exercise program builds on the Otago and FaME exercise programs which have shown to be effective in preventing falls. Strong and steady has been adapted to more functionally fit older people.
The study period will be one year. Due to the corona pandemic all S\&S groups in Norway have been closed. Due to this all participants have had a break from their exercise program for more than 6 months and can be seen av new participants to the exercise groups. Participants that are about to start in a S\&S group in municipalities in Trøndelag will be asked to participate in this study. They will go through tests of muscle strength and balance in addition to questionnaires at baseline and after 6 and 12 months of exercise. Where possible the participants will go through the same tests 1 month before they start to exercise in addition to the three other test timepoints.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Strong & Steady exercise programWill start a Strong \& Steady group exercise programme immediately after baseline testing. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to get to the training facilities on their own
- Able to walk without a walking aid indoors
Key exclusion criteria (1 listed)
- Diagnosed with dementia
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 |
|---|---|---|
| Strong & Steady exercise programThe community-based group exercise program S\&S, with strengthening and balance exercise as the main components. The participants will attend a once-weekly, one hour supervised session. The exercises that will be used can be found in the S\&S handbook which includes different difficulty levels. All instructors are volunteers and have completed the S\&S education. Each exercise session will consist of a warm-up (5-8 min.), endurance exercises (10-15 min.), strength exercises (15 min.), balance exercises (20 min.) and a cool down/stretching (5 min.). In addition to attending the group exercises, the participants will be taught and encouraged to do home exercises twice a week from hand out leaflets that can be found at www.sterkogstodig.no. | Behavioural | Intervention |
Primary outcome
30 sec chair rise
Time frame: Baseline and 3 months
Change in number of stands from a chair managed within a time frame of 30 seconds.
6 secondary outcomes
Short Physical Performance Battery total score
Time frame: Baseline, 3, 6 and 12 months
Number of falls
Time frame: 12 months
The Short Falls Efficacy Scale-International
Time frame: Baseline, 3, 6 and 12 months
Everyday physical activity
Time frame: One week monitoring at baseline, 3, 6 and 12 months
30 sec chair rise
Time frame: Baseline, 6 and 12 months
Four square step test
Time frame: Baseline, 6 and 12 months
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 Apr 2022.
- The national website for Sterk og stødigLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be fully anonymised 5 years after study completion and made available for other researcher by 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.
Jorunn L Helbostad, PhD/Prof study director
The Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong & Steady exercise program in people with Aged, run by Norwegian University of Science and Technology 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 2 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: finished, as of the sponsor's last update on 4 Apr 2022. 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?
30 sec chair rise (time frame: Baseline and 3 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 4 Apr 2022.