Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127539
• Other study ID #: 2019/255
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aged

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

External Links

•   The national website for Sterk og stødig