NCT06076278

Brief Summary

Knee osteoarthritis is a degenerative pathology that is characterized by structural changes in the joint, such as joint space narrowing, thickening of the joint capsule, and cartilage degeneration that encourages friction between the bone surfaces and causes pain, which is thought to be a major symptom of knee osteoarthritis. Knee osteoarthritis (OA) treatment focuses on reducing pain while also enhancing function and quality of life by resistant training and Home-based exercise, a time-effective and practical treatment option for people with chronic conditions. As the past literature states that home based trainings are cost and time effective, However there is deficient evidence regarding effectiveness of home based strength training in case of knee osteoarthritis. More evidence is therefore needed in this regard.

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
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 30, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

September 13, 2023

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Pain severity

    Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.The higher the score the greater will be pain severity

    4 week

  • Disability level of participant

    Disability will be assessed using Western Ontario and McMaster University Osteoarthritis Index. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations

    4 weeks

  • Muscle strength

    measured by using Modified Sphygmomanometer Dynamometry

    4 weeks

  • Gait Cadence

    Cadence (steps/min) = steps counted x 60/time (s)

    4 weeks

  • Range of motion

    Description measured by using Goniometer

    4 weeks

  • Gait Stride length

    Stride length (m) = speed (m/s) x cycle time (s)

    4 weeks

  • Gait Speed

    Gait Speed (m/s) = distance (m) / time (s)

    4 weeks

Study Arms (2)

Group A (Resistant Training)

ACTIVE COMPARATOR

Patients in this group will recieve Clinic based resistant training . A total of 12 sessions will be conducted over a period of 4 week 3 days a week.

Procedure: resistance exercise

Group B (Home Based resistant training)

EXPERIMENTAL

Patients will recieve home based resistant training. A total of 12 sessions will be conducted over a period of 4 week ,3 days a week .

Procedure: resistance exercise

Interventions

Isometrics contraction of quadriceps Supine straight leg raise Leg lifts in prone position Passive knee flexion Passive knee extension Resistance knee extension Resistance knee flexion Isometric terminal knee extension in lying and mini-squat Concentric and isometric knee extension and flexion in sitting Frequency: A total of 12 sessions, thrice a week, for 4 consecutive weeks. Time Duration: Approx. 25 to 30minutes

Group A (Resistant Training)Group B (Home Based resistant training)

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 25 to 60 years experiencing knee pain.
  • Both male and female.
  • Patients with grade 1 to 3 OA based on Kellgren Lawrence classification of knee OA.
  • Those participants with 4-8 on NPRS

You may not qualify if:

  • Individuals with serious pathology such as malignancy, inflammatory disorder or infection.
  • Individual with history of knee surgery or replacement.
  • Those patients who have received physiotherapy from last 2 months.
  • Those patients who have received any surgical treatment for SIJ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Abdullah Khan, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive home based resistant training and the second will receive clinic based resistant training. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 10, 2023

Study Start

August 30, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations