NCT04423432

Brief Summary

Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.

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
36

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 5, 2020

Last Update Submit

June 8, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Knee Pain: Numeric Pain Rating Scale

    Knee Pain will be quantified by using Numeric Pain Rating Scale

    4 weeks

  • Knee Range of Motion

    Knee Range of Motion will be quantified by using Gonimeter

    4 weeks

  • Knee Isometric Muscle Strength

    Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer

    4 weeks

  • Six Minute Walk Test

    Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.

    4 weeks

Secondary Outcomes (4)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    4 weeks

  • Body Composition

    4 weeks

  • Fall Risk

    4 weeks

  • Postural Stability

    4 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR
Other: Lower Extremity Resistance Exercise TrainingOther: Home Exercise PlanDevice: Electrotherapy + HeatingProcedure: Joint Mobilization

Creatine Supplementation

EXPERIMENTAL
Other: Lower Extremity Resistance Exercise TrainingOther: Home Exercise PlanDevice: Electrotherapy + HeatingProcedure: Joint MobilizationDietary Supplement: Creatine Supplementation

Glucoseamine/ Chondritin Sulfate Supplementation

EXPERIMENTAL
Other: Lower Extremity Resistance Exercise TrainingOther: Home Exercise PlanDevice: Electrotherapy + HeatingProcedure: Joint MobilizationDietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation

Interventions

3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)

Also known as: Lower Extremity Strength Training
ControlCreatine SupplementationGlucoseamine/ Chondritin Sulfate Supplementation

2 sets of 10 repetitions/day of 1. AROM isolated knee extension and knee flexion 2. Isometric isolated knee extension and knee flexion 3. Isometric terminal knee extension 4. Sit to stand squat terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

ControlCreatine SupplementationGlucoseamine/ Chondritin Sulfate Supplementation

Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes

ControlCreatine SupplementationGlucoseamine/ Chondritin Sulfate Supplementation

1. Tibio-femoral Anterior Glide 2. Tibio-femoral Posterior Glide 3. Patellofemoral Joint Mobilization

Also known as: Manual Therapy
ControlCreatine SupplementationGlucoseamine/ Chondritin Sulfate Supplementation
Creatine SupplementationDIETARY_SUPPLEMENT

Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks

Also known as: Creatine Monohydrate
Creatine Supplementation

Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)

Glucoseamine/ Chondritin Sulfate Supplementation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years
  • Knee OA with history not less than three months.
  • Radiological evidences of grade III or less on Kellgren classification.
  • Knee pain on VNRS no more than 8/10

You may not qualify if:

  • Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
  • Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
  • History of trauma or fractures in lower extremity.
  • Signs of lumbar radiculopathy or myelopathy.
  • History of knee surgery or replacement.
  • Patients on intra-articular steroid therapy within two months before the commencement of the study.
  • Impaired skin sensation.
  • Impaired renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences

Islamabad, Federal, 45710, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electric Stimulation TherapyMusculoskeletal ManipulationsCreatine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationComplementary TherapiesGuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Muhammad Osama, PhD*

    Foundation University Institute of Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Osama, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

January 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations