Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

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

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.

Study Overview

• Status: Completed
• Conditions: Aged
• Intervention / Treatment: Behavioral: Strong & Steady exercise program

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Norwegian municipalities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Will start a Strong & Steady group exercise programme immediately after baseline testing.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of falls	Number of falls will be collected by daily calendars collected every month	12 months
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
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
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
Four square step test	Time spent doing a sequence of moving through four squares back and fourth.	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Glasgow Caledonian University; Fysiofondet
• Investigators: Study Director: Jorunn L Helbostad, PhD/Prof, The Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Fall prevention
• Other Study ID Numbers: 2019/255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be fully anonymised 5 years after study completion and made available for other researcher by request.
• IPD Sharing Time Frame: 5 years after study completion
• IPD Sharing Access Criteria: By request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No