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CompletedNCT04127539Updated Apr 4, 2022

Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

An interventional study of Strong & Steady exercise program in Aged, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
65 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Aged

Keywords

  • Exercise
  • Fall prevention
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In context

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Able to get to the training facilities on their own
  • Able to walk without a walking aid indoors

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with dementia
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Intervention

    Will start a Strong \& Steady group exercise programme immediately after baseline testing.

    Behavioral: Strong & Steady exercise program

Interventions

  • BehavioralStrong & Steady exercise program

    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.

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What researchers measure

Primary outcomes

  1. 30 sec chair rise

    Change in number of stands from a chair managed within a time frame of 30 seconds.

    Time frame: Baseline and 3 months

Secondary outcomes

  1. 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).

    Time frame: Baseline, 3, 6 and 12 months

  2. Number of falls

    Number of falls will be collected by daily calendars collected every month

    Time frame: 12 months

  3. 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.

    Time frame: Baseline, 3, 6 and 12 months

  4. 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.

    Time frame: One week monitoring at baseline, 3, 6 and 12 months

  5. 30 sec chair rise

    Change in number of stands from a chair managed within a time frame of 30 seconds.

    Time frame: Baseline, 6 and 12 months

  6. Four square step test

    Time spent doing a sequence of moving through four squares back and fourth.

    Time frame: Baseline, 6 and 12 months

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Study locations

1 site
  • Norwegian municipalities
    Trondheim, Norway
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References and documents

Individual participant data

Plan to share: Yes — Data will be fully anonymised 5 years after study completion and made available for other researcher by request.

Supporting information: Study protocol, Sap, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04127539
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Glasgow Caledonian University, Fysiofondet
Responsible party
Sponsor
First posted
Oct 15, 2019
Start date
Sep 14, 2020
Primary completion
Dec 20, 2021
Completion
Dec 20, 2021
Last update
Apr 4, 2022

Study contacts

Jorunn L Helbostad, PhD/Prof
study director · The Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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