NCT07649863

Brief Summary

Knee osteoarthritis, a chronic musculoskeletal disease, is the most prevalent type of osteoarthritis and the leading cause of disability and major healthcare costs worldwide. The pathogenesis of the disease is not fully understood and there are few non-invasive disease-modifying therapies available to patients. Therefore, there is a critical need to enhance therapeutic interventions, which requires improvement of our understanding of knee osteoarthritis pathogenesis. Increasing evidence suggests that physical activity and exercise training are cost-effective and widely available interventions for the treatment of knee osteoarthritis, however, consideration of type of physical activity and optimal exercise modality are needed to reduce pain, improve gait, knee joint function, stiffness, and muscle weakness in individuals with knee osteoarthritis. The aim of this pilot clinical trial is to compare individuals with knee osteoarthritis who have not exercised with individuals that have performed retro walking exercise chosen from the systematic review and survey we have conducted previously to reduce pain and improve gait. Non-linear analyses will be performed to determine the effects of exercise intervention on gait biomechanics and stability of movement in these patients. These findings may form a basis for recommendations of exercise/physical activity interventions for the benefits of patients with knee osteoarthritis including pain reduction, mobility improvement and gait modification.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

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

Study Progress23%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

May 18, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

May 18, 2026

Last Update Submit

June 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee function and associated frequency and severity of pain

    Participants' opinion about their own knee function and associated problems will be assessed through self-administered and validated questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS questionnaire designed to collectively evaluate and measure five outcomes in individuals with knee osteoarthritis including: Pain: Frequency and severity of knee pain. Symptoms: Swelling, grinding, stiffness, and range of motion issues. Activities of Daily Living (ADL): Difficulty with physical tasks like stairs, rising from a seat, or getting in and out of a car. Sports and Recreation Function: The ability to perform higher-level physical activities, such as running, squatting, or playing sports. Quality of Life (QOL): Knee-related lifestyle limitations and personal awareness of the joint.

    Baseline or Day 1 and end of study at 6 weeks

Secondary Outcomes (14)

  • Pain intensity

    Baseline or Day 1 up to 6 weeks

  • The gait biomechanics - change from baseline in spatiotemporal parameter walking speed at 6 weeks

    Baseline or Day 1 and end of study at 6 weeks

  • The gait biomechanics - change from baseline in spatiotemporal parameter cadence at 6 weeks

    Baseline or Day 1 and end of study at 6 weeks

  • The gait biomechanics - change from baseline in spatiotemporal parameter stride/step length at 6 weeks

    Baseline or Day 1 and end of study at 6 weeks

  • The gait biomechanics - change from baseline in spatiotemporal parameter swing/stance phases at 6 weeks

    Baseline or Day 1 and end of study at 6 weeks

  • +9 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Participants in the intervention group will perform treadmill retro walking exercise 3 days/week for 6 weeks.

Other: Retro walking (backwards walking) on a treadmill

Control

NO INTERVENTION

Participants in the control group will maintain their existing level of activity.

Interventions

Prior to the intervention participants will be made familiar with retro walking on the treadmill. The exercise will consist of a forward walking for 5min on the treadmill for warm-up followed by retro walking for 10min and a cool-down for 5min. Participants will be instructed to increase their retro walking time up to 30min if the pain sensation continuously was reduced (pain scores \< 3 numerical rating scale). The comfortable speed of the retro walking will be determined by the participant under supervision of the researchers. No slopes or inclination will be used in this study for participant safety. In the warm-up and cool-down sessions participants will be asked to perform muscle stretch, ankle toe movements and heel raise exercises.

Also known as: Exercise
Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female
  • Any ethnicity
  • Adults over 18 years old
  • Meet the UK guidelines for physical activity supported by NICE (National Institute for Health and Care Excellence) and NHS (able to exercise if it is safe with regular breaks)
  • Otherwise, adults with clinically diagnosed knee osteoarthritis according to NICE criteria or confirmed by a healthcare professional able and willing to participate and provide written informed consent

You may not qualify if:

  • Any musculoskeletal injury
  • Any conditions known to affects gait (e.g. Parkinson's disease or stroke)
  • Any surgical intervention in the previous 12 months on lower limbs
  • Surgical replacement of hip or knee joints
  • BMI (body mass index) over 35
  • Athletes or take part in significant recreational activity
  • Takes any medication known to affect the gait and ability to walk
  • Received an intra-articular injection in the last 3 months
  • Have been told by medical professionals that they should not take part in any intensity exercise/physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hasmik J Samvelyan, PhD

CONTACT

Nathan Bytheway, MEng

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 16, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 16, 2026

Record last verified: 2026-03