- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07490977
Cross-Education From Unilateral Strength and Balance Training in Older Adults With Bilateral Knee Osteoarthritis
Cross-Education of Combined Unilateral Strength and Balance Training on Motor Function in Older Adults With Bilateral Knee Osteoarthritis
Kinesitherapy is one of the main tools in the rehabilitation of knee osteoarthritis, but is often limited due to pain, reduced functionality, and fear of falling in older adults. This study will, through three sub-studies, examine the effects of unilateral training programs on strength, movement control, balance, and pain in the contralateral leg, as well as on functionality, fall risk, and kinesiophobia in older adults with bilateral knee osteoarthritis through three sub-studies. A total of 45 participants (aged 60-80 years) with bilateral knee osteoarthritis will be randomly assigned to one of three groups: 1. combined unilateral strength and balance training; 2. unilateral balance training; 3. unilateral strength training. Strength will be measured with maximal voluntary contraction, balance using a single leg stance test on an unstable surface, movement control with an active joint position reproduction test, and functionality using the six-minute walk test and the Western Ontario and McMaster Osteoarthritis Index questionnaire. Pain will be assessed with the Visual Analog Scale and the Intermittent and Constant Osteoarthritis Pain questionnaire, fall risk with the Timed Up and Go test and the Falls Efficacy Scale-International questionnaire, and kinesiophobia using the TAMPA questionnaire. This study will expand knowledge on cross-transfer and its effects on symptoms in the rehabilitation of older adults with bilateral knee osteoarthritis.
This research is a part of a doctoral thesis conducted under the supervision of assoc. prof. Tatjana Trošt, PhD.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: 8-Week Unilateral Strength and Balance Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis
- Other: 8-Week Unilateral Balance Training Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis
- Other: 8-Week Unilateral Strength Training Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lara Juriša, PhD candidate
- Phone Number: 00385989165960
- Email: lara.jurisa@kif.unizg.hr
Study Contact Backup
- Name: Assoc. Prof. Tatjana Trošt, PhD
- Email: tatjana.trost@kif.unizg.hr
Study Locations
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-
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Zagreb, Croatia, 10000
- University of Zagreb Faculty of Kinesiology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 60-80 years,
- bilateral knee osteoarthritis of grade II-III according to the Kellgren-Lawrence classification
Exclusion Criteria:
- acute lower extremity injuries in the past year,
- taking nonsteroidal anti-inflammatory drugs within the past month,
- involvement in physical therapy within the past 6 months,
- undergoing intra-articular injections and/or knee surgery within the past year,
- rheumatoid arthritis, septic arthritis, uncontrolled diabetes, other systemic inflammatory and autoimmune diseases, and severe cardiovascular, renal, and hepatic comorbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Unilateral strength and balance training group
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Participants perform unilateral exercises with the less affected leg, combining strength and balance training.
Each session lasts 50 minutes, including warm-up, main exercises (15-20 min), and relaxation.
The program consists of 24 sessions over 8 weeks.
|
|
Experimental: Unilateral balance training group
|
Participants perform unilateral balance exercises with the less affected leg.
Each 50-minute session includes warm-up, 15-20 minutes of main balance exercises, and relaxation.
The program lasts 8 weeks with 24 sessions.
|
|
Experimental: Unilateral strength training group
|
Participants perform unilateral strength exercises with the less affected leg.
Each 50-minute session includes warm-up, 15-20 minutes of main strength exercises, and relaxation.
The program lasts 8 weeks with 24 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in balance performance in older adults with bilateral knee osteoarthritis after 8 weeks of unilateral strength and/or balance training across all three intervention groups
Time Frame: From baseline (pre-intervention) to the end of the 8-week training program
|
From baseline (pre-intervention) to the end of the 8-week training program
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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