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Completed

NCT Number: NCT04127539

Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

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.

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Key information

Conditions

Aged Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian municipalities

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosed with dementia

Treatment and study plan

Strong & Steady exercise program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Short Physical Performance Battery total score

    Time frame: Baseline, 3, 6 and 12 months

    Includes 5x Sit-to-stand, 4 meters walk test and 3 different 10 sec stance positions. Change in total score (0-12 points).

  2. Number of falls

    Time frame: 12 months

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

  3. The Short Falls Efficacy Scale-International

    Time frame: Baseline, 3, 6 and 12 months

    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.

  4. Everyday physical activity

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

    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.

  5. 30 sec chair rise

    Time frame: Baseline, 6 and 12 months

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

  6. Four square step test

    Time frame: Baseline, 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Fysiofondet
  • Glasgow Caledonian University

Registry information

Official study title

Evaluation of Strong & Steady: A Group Exercise Program for Preventing Functional Decline and Falls Among Community Dwelling Older Adults

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2019
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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