NCT07198204

Brief Summary

this stuy tries to evaulate the best contraction (hold time) during isometric effort that can provide the best therapeutic effects on muscular performance in patients with knee osteoarthritis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

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

First Submitted

Initial submission to the registry

September 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 15, 2025

Last Update Submit

September 20, 2025

Conditions

Keywords

kneearthritisstrengthcontraction timeisometric

Outcome Measures

Primary Outcomes (4)

  • pain by numeric pain rating scale

    The Numeric Pain Rating Scale (NPRS) is the simplest and most commonly used numeric scale to rate pain, ranging from 0 (no pain) to 10 (worst pain). The NPRS will be used for subjective pain measurement, which has good test-retest reliability

    at baseline and after 1month of trreatment

  • Function using Western Ontario and McMaster Universities Osteoarthritis

    We will focus only on stiffness and physical function. The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) has been widely used by clinicians in assessing patients with knee OA since it was developed in 1986 (Bellamy, 1995) to evaluate the symptoms of pain, stiffness, and physical function in patients with hip and/or knee OA. It consists of 24 questions and is divided into 3 subgroups: the pain subgroup consists of 5 questions, the stiffness subgroup consists of 2 questions, and the physical function subgroup consists of 17 questions. Each question receives a value between 0 and 4, and the total score is calculated as follows: no difficulty is scored as 0, mild as 1, moderate as 2, severe as 3, and extreme as 4. Higher scores indicate greater physical dysfunction and disability, and thereby worse health-related quality of life

    will be assessed at baseline and after 1 month of treatement

  • function using Five Times Sit to Stand Test

    The muscle strength of the lower limbs was measured by the Five-Times-Sit-to-Stand Test (FTSST), in which participants rise from a chair and return to a seated position as quickly as possible with their arms folded across their chests. The time to complete five repetitions was recorded for two separate trials, with a 1-minute rest between each trial. The mean of the two trials was computed and used in the analysis

    at baseline and after 1month of treatment

  • muscle strength using the one-repetition maximum (1RM) test for knee extension

    1RM test has good-to-excellent test-retest reliability. the participants will be asked to perform active knee extension against different pregressive increasing weigths to determine the 1 RM. 2 minutes rest will be allowed before each contraction effort to allow recovery of the tested muscle.

    at baseline and after 1 month of treatement

Study Arms (4)

group 1

EXPERIMENTAL

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight-leg raising, and isometric hip adduction exercises for 5 seconds. All exercises will be performed in sets of 12 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 5 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of maximum voluntary contraction (MVC).

Other: isometric exercisesOther: therapeutic ultrasoundOther: Transcutanous electrical nerve stimulation

group 2

EXPERIMENTAL

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 10 sec. All exercises will be performed in sets of 6 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 10 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

Other: isometric exercisesOther: therapeutic ultrasoundOther: Transcutanous electrical nerve stimulation

group 3

EXPERIMENTAL

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 20 sec. All exercises will be performed in sets of 3 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 20 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

Other: isometric exercisesOther: therapeutic ultrasoundOther: Transcutanous electrical nerve stimulation

control group

ACTIVE COMPARATOR

The control group will receive ultrasound therapy and TENS only.

Other: therapeutic ultrasoundOther: Transcutanous electrical nerve stimulation

Interventions

Isometric quadriceps exercise: Patients lie in a supine position. A rolled-up towel was put beneath the knee. They were instructed to maximally activate their thigh muscles to straighten their knee and hold the contraction for 5 seconds (Group A), 10 seconds (Group B), or 20 seconds (Group C).

group 1group 2group 3

all patients will reciece ultrasound for 5 minutes using 1MHz frequency, 0.8 wc2, 5cm2 head with adequate gel as a coupling medium

control groupgroup 1group 2group 3

all participants will recieve TENS for 30 minutes per session. the parameters will be Burst TENS, with main frequency of 100Hz, burst frequency of 4 Hz, intensity to the comfortable muscle twitch, electrodes size according to the size of the patients knee.

control groupgroup 1group 2group 3

Eligibility Criteria

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

You may qualify if:

  • prediagnosed case of knee OA as per the American College of Rheumatology (ACR) and radiological evidence of primary osteoarthritis of grade 3 or less on the Kellgren Lawrence scale;
  • age between 40-65 years, including both men and women.
  • unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included).

You may not qualify if:

  • Other knee joint pathologies, eg, Chondromalacia patella, plica syndrome,
  • Neurological disorders.
  • Patients having lower extremity injury/surgeries in the past 6 months,
  • Hip or knee fractures or deformity,
  • joint infections and inflammatory joint disease,
  • physical therapy on the knee within the last 3 months or steroid injections,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis

Interventions

ExerciseUltrasonic Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiathermyHyperthermia, InducedTherapeutics

Central Study Contacts

Hisham Hussein, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 30, 2025

Study Start

November 30, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

data will be used in future research