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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Lower Extremity Resistance Exercise Training
* Other: Home Exercise Plan
* Device: Electrotherapy + Heating
* Procedure: Joint Mobilization
* Dietary Supplement: Creatine Supplementation
* Dietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Other: Lower Extremity Resistance Exercise Training<br>* 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)<br>* Other names: Lower Extremity Strength Training;Other: Home Exercise Plan<br>* 2 sets of 10 repetitions/day of AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)<br>Device: Electrotherapy + Heating<br>* Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes<br>Procedure: Joint Mobilization<br>* Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization<br>* Other names: Manual Therapy;|
| Experimental: Creatine Supplementation<br> | Other: Lower Extremity Resistance Exercise Training<br>* 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)<br>* Other names: Lower Extremity Strength Training;Other: Home Exercise Plan<br>* 2 sets of 10 repetitions/day of AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)<br>Device: Electrotherapy + Heating<br>* Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes<br>Procedure: Joint Mobilization<br>* Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization<br>* Other names: Manual Therapy;Dietary Supplement: Creatine Supplementation<br>* Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks<br>* Other names: Creatine Monohydrate;|
| Experimental: Glucoseamine/ Chondritin Sulfate Supplementation<br> | Other: Lower Extremity Resistance Exercise Training<br>* 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)<br>* Other names: Lower Extremity Strength Training;Other: Home Exercise Plan<br>* 2 sets of 10 repetitions/day of AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)<br>Device: Electrotherapy + Heating<br>* Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes<br>Procedure: Joint Mobilization<br>* Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization<br>* Other names: Manual Therapy;Dietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation<br>* Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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 | Body Composition will be quantified by using Bioelectrical Impedance | 4 weeks | 
| Fall Risk | Fall risk will be quantified by using Biodex balance System | 4 weeks | 
| Postural Stability | Postural Stability will be quantified by using Biodex balance System | 4 weeks |