NCT03628508

Brief Summary

Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 24, 2021

Completed
Last Updated

September 16, 2021

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

August 6, 2018

Results QC Date

November 25, 2020

Last Update Submit

August 24, 2021

Conditions

Keywords

muscle tensionalignmentknee osteoarthritisloading

Outcome Measures

Primary Outcomes (1)

  • Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System

    External knee moment in the frontal plane during early stance phase of walking

    At baseline and one week after intervention

Secondary Outcomes (3)

  • Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score

    At baseline and one week after intervention

  • Tibial Torsion as Assessed by X-ray Imaging

    At baseline

  • Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography

    At baseline and one week after intervention

Study Arms (1)

Exercise

EXPERIMENTAL

Six-week exercise including stretching, strengthening, endurance and gait modification

Other: Exercise

Interventions

Comprehensive exercise program including strengthening, stretching, gait modification etc.

Exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 50-80
  • having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
  • having medial knee pain on most days of the month
  • having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking

You may not qualify if:

  • having lateral tibiofemoral compartment osteophytes greater than the medial side.
  • having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
  • having a systemic arthritic condition (e.g., rheumatoid arthritis)
  • having a knee joint replacement or high tibial osteotomy in the past
  • having any other muscular, joint or neurological condition influencing lower limb function
  • unable to walk unaided
  • having low back, hip, ankle or foot pain \> 3 on numerical rating scale
  • having a body mass index (BMI) \>36 kg/ m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr Amy Fu
Organization
The Hong Kong Polytechnic University

Study Officials

  • Siu Ngor Fu, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 14, 2018

Study Start

March 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 16, 2021

Results First Posted

March 24, 2021

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations