- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05551000
Functional vs Traditional Training in Older Women's Health
March 2, 2026 updated by: Lasse Engberg Treu Lassen, Aalborg University
Functional vs Traditional Group-Based Training in Community-Dwelling Older Women: A Cluster Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Steinkjer, Norway, 7714
- SSA Steinkjer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
61 years to 71 years (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Illness or injury within the last three months.
- Do not have the ability to complete the test battery concerning set minimum criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
This group will use a functional training system developed specifically for elderlies to improve everyday movements, physical strength and balance.
|
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.
|
|
Active Comparator: Positive control
This group will use a general training system developed for elderlies to improve everyday movements, physical strength and balance.
|
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.
|
|
No Intervention: Negative control
Control group: A group that is not treated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Y-Balance Test
Time Frame: Day 1
|
Measure balance performance (Cm)
|
Day 1
|
|
Y-Balance Test
Time Frame: 2 months
|
Measure balance performance (Cm)
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility test
Time Frame: Day 1
|
Chair-sit-and-reach and back scratch test (Cm)
|
Day 1
|
|
Mobility test
Time Frame: 2 months
|
Chair-sit-and-reach and back scratch test (Cm)
|
2 months
|
|
Strength Test
Time Frame: Day 1
|
Chair stand and Arm curl test (Repetitions)
|
Day 1
|
|
Functional Strength Test
Time Frame: 2 months
|
Chair stand and Arm curl test (Repetitions)
|
2 months
|
|
Time up-and-go test
Time Frame: Day 1
|
Measure agility (Secounds)
|
Day 1
|
|
Time up-and-go test
Time Frame: 2 months
|
Measure agility (Secounds)
|
2 months
|
|
6-minute walking test
Time Frame: Day 1
|
Measure walking distance (Meters)
|
Day 1
|
|
6-minute walking test
Time Frame: 2 months
|
Measure walking distance (Meters)
|
2 months
|
|
SF-36 questionnaire
Time Frame: 2 months
|
Measure the participant's Health-related quality of life
|
2 months
|
|
SF-36 questionnaire
Time Frame: 1 day
|
Measure the participant's Health-related quality of life
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
December 22, 2023
Study Completion (Actual)
December 22, 2023
Study Registration Dates
First Submitted
September 20, 2022
First Submitted That Met QC Criteria
September 20, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 438956
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Performance Enhancement
-
St. Mary's University, TwickenhamNot yet recruitingPerformance EnhancementUnited Kingdom
-
United States Army Aeromedical Research LaboratoryCompletedPerformance EnhancementUnited States
-
Coşkun YILMAZCompletedAthletic Performance | Neuromuscular Adaptations | Athletic Performance EnhancementTurkey (Türkiye)
-
Louisiana State University Health Sciences Center...CompletedMuscle Activation | Performance EnhancementUnited States
-
Elif TurgutHacettepe UniversityRecruitingShoulder | Athlete | Performance EnhancementTurkey (Türkiye)
-
Istanbul Topkapi UniversityCompletedCyclists | Performance Enhancement | Isokinetic TestTurkey (Türkiye)
-
Ulaş Can YILDIRIMCompletedCognitive Performance | Physical Performance Enhancement | Caffeine and L-theanine InteractionTurkey (Türkiye)
-
Karolinska InstitutetCompletedMental Health | Performance Anxiety | Performance EnhancementSweden
-
Salih ÇABUKCompletedAnaerobic Performance | Athletic Performance Enhancement (Kickboxing) | Strength Endurance | Neuromuscular Power | Nutritional Supplementation (β-Alanine)Turkey (Türkiye)
Clinical Trials on Experimental, comparator and control
-
Aalborg UniversityThe Research Council of NorwayCompleted
-
Aalborg UniversityThe Research Council of NorwayCompleted
-
SÜMEYYE BİLGİLİ TEKİNAtaturk UniversityRecruitingOral ComplicationTurkey (Türkiye)
-
Centro de Atenção ao Assoalho PélvicoCompletedBreast Cancer | Atrophy;VaginalBrazil
-
University of HullHull University Teaching Hospitals NHS TrustRecruitingOrthopedic DisorderUnited Kingdom
-
Finis Terrae UniversityNot yet recruitingPostoperative Pain | Respiratory ComplicationChile
-
Hasan Kalyoncu UniversityNot yet recruitingOsteoarthritis, KneeTurkey
-
University of PadovaDepartment of Neuroscience, University of PadovaCompleted
-
Olivier HugliUniversity of Lausanne HospitalsCompletedPain, Acute | Catheterization, PeripheralSwitzerland
-
Region SkaneLund UniversityCompletedGlucose Intolerance