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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04127539
Other study ID # 2019/255
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date December 20, 2021

Study information

Verified date March 2022
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date December 20, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Strong & 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.

Locations

Country Name City State
Norway Norwegian municipalities Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Fysiofondet, Glasgow Caledonian University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30 sec chair rise Change in number of stands from a chair managed within a time frame of 30 seconds. Baseline and 3 months
Secondary 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). Baseline, 3, 6 and 12 months
Secondary Number of falls Number of falls will be collected by daily calendars collected every month 12 months
Secondary 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. Baseline, 3, 6 and 12 months
Secondary 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. One week monitoring at baseline, 3, 6 and 12 months
Secondary 30 sec chair rise Change in number of stands from a chair managed within a time frame of 30 seconds. Baseline, 6 and 12 months
Secondary Four square step test Time spent doing a sequence of moving through four squares back and fourth. Baseline, 6 and 12 months
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