Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Despite the past decade being dedicated to bone and joint disease, the incidence and prevalence rates of osteoarthritis continues to rise, and till date not curative treatment has been identified for the management of knee osteoarthritis. In terms of conservative management of knee osteoarthritis, pharmacological management has been the mainstay of treatment, however is associated with numerous adverse effects with prolonged use, and it is important to look into the non-pharmacological alternates for the management of knee osteoarthritis. Research has shown resistance exercise training to be the most effective non-pharmacological treatment option for the management of knee osteoarthritis, and the purpose of the current study is to determine if the addition of a non-pharmacological dietry supplement like creatine can amplify the beneficial effects of resistance exercise training in patients with knee osteoarthritis.

Official Title
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Effects of Creatine Supplementation in Addition to Resistance Exercise Training 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


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>* Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) 3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure) 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<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 Isometric knee terminal extension<br>Device: Electrotherapy + Heating<br>* Interferential 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>* Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM) 3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure) 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval<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 Isometric knee terminal extension<br>Device: Electrotherapy + Heating<br>* Interferential 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain: Visual Analogue Scale | Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity. | 2 weeks | 
| Knee Pain: Visual Analogue Scale | Visual Analogue Scale was used to measure pain scoring from 0-10 cm on a horizontal 10cm line. A greater score reflects higher pain intensity. | 4 weeks | 
| Knee Range of Motion | Knee Range of Motion will be quantified by using Gonimeter | 2 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 | 2 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, walking distance and walking speed. | 2 weeks | 
| Six Minute Walk Test | Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed. | 4 weeks | 
| 5 repetition sit to stand test | Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score. | 2 weeks | 
| 5 repetition sit to stand test | Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%. | 2 weeks | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%. | 4 weeks | 
| Body Composition | Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity. | 2 weeks | 
| Body Composition | Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity. | 4 weeks | 
| Fall Risk | Fall risk will be quantified by using Biodex balance System | 2 weeks | 
| Fall Risk | Fall risk will be quantified by using Biodex balance System | 4 weeks |