NCT07490977

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 24, 2026

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    From baseline (pre-intervention) to the end of the 8-week training program

Study Arms (3)

Unilateral strength and balance training group

EXPERIMENTAL
Other: 8-Week Unilateral Strength and Balance Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis

Unilateral balance training group

EXPERIMENTAL
Other: 8-Week Unilateral Balance Training Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis

Unilateral strength training group

EXPERIMENTAL
Other: 8-Week Unilateral Strength Training Program for the Less Affected Leg in Older Adults With Bilateral Knee Osteoarthritis

Interventions

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.

Unilateral strength and 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.

Unilateral balance 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.

Unilateral strength training group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-80 years,
  • bilateral knee osteoarthritis of grade II-III according to the Kellgren-Lawrence classification

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zagreb Faculty of Kinesiology

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Aging

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Central Study Contacts

Lara Juriša, PhD candidate

CONTACT

Assoc. Prof. Tatjana Trošt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 24, 2026

Record last verified: 2025-05

Locations