Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis

June 8, 2020 updated by: Foundation University Islamabad
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 45710
        • Recruiting
        • Foundation university institute of rehabilitation sciences
        • Contact:
        • Principal Investigator:
          • Muhammad Osama, PhD*

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Lower Extremity Resistance Exercise Training
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)
Other Names:
  • Lower Extremity Strength Training
Other: Home Exercise Plan

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)

Device: Electrotherapy + Heating
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
Procedure: Joint Mobilization
  1. Tibio-femoral Anterior Glide
  2. Tibio-femoral Posterior Glide
  3. Patellofemoral Joint Mobilization
Other Names:
  • Manual Therapy
Experimental: Creatine Supplementation
Dietary supplement: Creatine Supplementation
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Other Names:
  • Creatine Monohydrate
Other: Lower Extremity Resistance Exercise Training
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)
Other Names:
  • Lower Extremity Strength Training
Other: Home Exercise Plan

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)

Device: Electrotherapy + Heating
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
Procedure: Joint Mobilization
  1. Tibio-femoral Anterior Glide
  2. Tibio-femoral Posterior Glide
  3. Patellofemoral Joint Mobilization
Other Names:
  • Manual Therapy
Experimental: Glucoseamine/ Chondritin Sulfate Supplementation
Other: Lower Extremity Resistance Exercise Training
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)
Other Names:
  • Lower Extremity Strength Training
Other: Home Exercise Plan

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)

Device: Electrotherapy + Heating
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
Procedure: Joint Mobilization
  1. Tibio-femoral Anterior Glide
  2. Tibio-femoral Posterior Glide
  3. Patellofemoral Joint Mobilization
Other Names:
  • Manual Therapy
Dietary supplement: Glucoseamine/ Chondritin Sulfate Supplementation
Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Pain: Numeric Pain Rating Scale
Time Frame: 4 weeks
Knee Pain will be quantified by using Numeric Pain Rating Scale
4 weeks
Knee Range of Motion
Time Frame: 4 weeks
Knee Range of Motion will be quantified by using Gonimeter
4 weeks
Knee Isometric Muscle Strength
Time Frame: 4 weeks
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
4 weeks
Six Minute Walk Test
Time Frame: 4 weeks
Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 4 weeks
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
4 weeks
Body Composition
Time Frame: 4 weeks
Body Composition will be quantified by using Bioelectrical Impedance
4 weeks
Fall Risk
Time Frame: 4 weeks
Fall risk will be quantified by using Biodex balance System
4 weeks
Postural Stability
Time Frame: 4 weeks
Postural Stability will be quantified by using Biodex balance System
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Collaborators

Isra University

Investigators

  • Principal Investigator: Muhammad Osama, PhD*, Foundation university institute of rehabilitation sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2020/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Creatine Supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe