NCT04909086

Brief Summary

This is a randomized controlled trial examining and compare the effects of open and closed kinetic chain exercises on pain, function, and cartilage synthesis and degradation biomarkers after an eight-week rehabilitation program for knee osteoarthritis (OA) patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

May 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

May 26, 2021

Last Update Submit

September 29, 2022

Conditions

Knee Osteoarthritis

Keywords

KneeOsteoarthritisKinetic exercisesBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Change in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index

    A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.

    Baseline, 2, and 6 months follow-up

  • Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index

    A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.

    Baseline, 2, and 6 months follow-up

Secondary Outcomes (5)

  • Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)

    Baseline, 2, and 6 months follow-up

  • Change in isometric muscle strength

    Baseline, 2, and 6 months follow-up

  • Change in knee joint range of motion (ROM)

    Baseline, 2, and 6 months follow-up

  • Change in knee joint proprioception

    Baseline, 2, and 6 months follow-up

  • Change in knee OA biomarkers

    Baseline, 2, and 6 months follow-up

Study Arms (3)

Standard Physical Therapy

ACTIVE COMPARATOR

Control group for the study.

Procedure: Standard physical Therapy

Open Kinetic Chain

EXPERIMENTAL

Standard care in addition to open kinetic chain exercises for the knee joint muscles.

Procedure: Open Kinetic Chain

Closed Kinetic Chain

EXPERIMENTAL

Standard care in addition to closed kinetic chain exercises for the knee joint muscles.

Procedure: Closed Kinetic Chain

Interventions

Standard physical TherapyPROCEDURE

Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle stretching, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.

Standard Physical Therapy
Closed Kinetic ChainPROCEDURE

Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of seated leg press and partial squat exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.

Closed Kinetic Chain
Open Kinetic ChainPROCEDURE

Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of Quadriceps seated strengthening and Hamstring curl-up exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.

Open Kinetic Chain

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥40 years of age;
  • having knee pain;
  • having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
  • willing to provide informed consent

You may not qualify if:

  • Knee joints showing Kellgren and Lawrence (K-L) grades 1 or 4;
  • rheumatoid arthritis;
  • serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on a waiting list for joint replacement surgery;
  • recent surgical procedure of the lower extremities in the previous 6 months;
  • uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
  • physical incapability to safely perform exercises, walking or stationary cycling, as in debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
  • use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
  • lack of clear comprehension of study procedures or inability to comply with instructions;
  • stated inability to attend or complete the proposed course of intervention and follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahd Military Medical Complex

Dammam, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ahmed Farrag, PhD

    Prince Sultan Military College of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Farrag, PhD

CONTACT

+966 38440000afarrag@psmchs.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Both the outcome assessors and the study statistician will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 1, 2021

Study Start

August 21, 2021

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)