NCT04127539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

October 14, 2019

Last Update Submit

April 1, 2022

Conditions

Keywords

ExerciseFall prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Short Physical Performance Battery total score

    Baseline, 3, 6 and 12 months

  • Number of falls

    12 months

  • The Short Falls Efficacy Scale-International

    Baseline, 3, 6 and 12 months

  • Everyday physical activity

    One week monitoring at baseline, 3, 6 and 12 months

  • 30 sec chair rise

    Baseline, 6 and 12 months

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Will start a Strong \& Steady group exercise programme immediately after baseline testing.

Behavioral: Strong & Steady exercise program

Interventions

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Able to get to the training facilities on their own
  • Able to walk without a walking aid indoors

You may not qualify if:

  • Diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian municipalities

Trondheim, Norway

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jorunn L Helbostad, PhD/Prof

    The Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 15, 2019

Study Start

September 14, 2020

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Data will be fully anonymised 5 years after study completion and made available for other researcher by request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
5 years after study completion
Access Criteria
By request

Locations