Evaluation of Strong & Steady - Fall Preventive Group Exercise Program

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT04127539
• Collaborator: Glasgow Caledonian University (Other), Fysiofondet (Other)
• Enrollment: 95
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.2
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aged	Behavioral: Strong & Steady exercise program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Strong & Steady: A Group Exercise Program for Preventing Functional Decline and Falls Among Community Dwelling Older Adults
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Dec 20, 2021
• Actual Study Completion Date: Dec 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. Number of falls [12 months]

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

3. 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.

4. 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.

5. 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.

6. Four square step test [Baseline, 6 and 12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norwegian municipalities	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• Glasgow Caledonian University
• Fysiofondet

Investigators

• Study Director: Jorunn L Helbostad, PhD/Prof, The Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The national website for Sterk og stødig

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04127539
• Other Study ID Numbers: 2019/255
• First Posted: Oct 15, 2019
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Exercise; Fall prevention

Study Results

No Results Posted as of Apr 4, 2022