Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

Not Applicable

Completed

• Conditions: Aged
• Interventions: Behavioral: Strong & Steady exercise program

• Registration Number: NCT04127539
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

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 Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2020-09-14
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Strong & Steady exercise program	Will start a Strong \& Steady group exercise programme immediately after baseline testing.

Primary Outcome Measures

Name	Time	Method
30 sec chair rise	Baseline and 3 months	Change in number of stands from a chair managed within a time frame of 30 seconds.

Secondary Outcome Measures

Name	Time	Method
Number of falls	12 months	Number of falls will be collected by daily calendars collected every month
Everyday physical activity	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.
Short Physical Performance Battery total score	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).
The Short Falls Efficacy Scale-International	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.
30 sec chair rise	Baseline, 6 and 12 months	Change in number of stands from a chair managed within a time frame of 30 seconds.
Four square step test	Baseline, 6 and 12 months	Time spent doing a sequence of moving through four squares back and fourth.

Trial Locations

Locations (1)

Norwegian municipalities; 🇳🇴 Trondheim, Norway