NCT05551000

Brief Summary

This study investigates how balance, mobility, strength, gait speed, and health-related quality of life in older adults (65+) are affected after an 8-week training period using the Norwegian national concept for older adults, Strong and Steady, compared to a modified version that incorporates functional training variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

September 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

September 20, 2022

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Y-Balance Test

    Measure balance performance (Cm)

    Day 1

  • Y-Balance Test

    Measure balance performance (Cm)

    2 months

Secondary Outcomes (10)

  • SF-36 questionnaire

    2 months

  • Mobility test

    2 months

  • Mobility test

    Day 1

  • SF-36 questionnaire

    1 day

  • 6-minute walking test

    2 months

  • +5 more secondary outcomes

Study Arms (3)

Intervention

EXPERIMENTAL

This group will use a functional training system developed specifically for elderlies to improve everyday movements, physical strength and balance.

Other: Experimental, comparator and control

Positive control

ACTIVE COMPARATOR

This group will use a general training system developed for elderlies to improve everyday movements, physical strength and balance.

Other: Experimental, comparator and control

Negative control

NO INTERVENTION

Control group: A group that is not treated.

Interventions

To quantify the effect of a training intervention for elderlies on improved range of motion, dynamic balance, gait speed, gait coordination, everyday movements and strength compared to a training group from the Norwegian elderly concept "Stærk og Stødig" and a control group.

InterventionPositive control

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderlies aged 65 to 75 years old.
  • Have been participating and physical training for at least six months before the start of the intervention.
  • The participants must be highly motivated for the project, which will be measured using the likard scale.

You may not qualify if:

  • Illness or injury within the last three months.
  • Do not have the ability to complete the test battery concerning set minimum criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSA Steinkjer

Steinkjer, 7714, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. candidate

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 22, 2022

Study Start

October 1, 2023

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations