Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lower Extremity Resistance Exercise Training
Home Exercise Plan
Electrotherapy + Heating
Joint Mobilization
Creatine Supplementation
Sponsored by

About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Foundation University Institute of Rehabilitation Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Creatine Supplementation
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Knee Range of Motion
Knee Range of Motion will be quantified by using Gonimeter
Knee Range of Motion
Knee Range of Motion will be quantified by using Gonimeter
Knee Isometric Muscle Strength
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Knee Isometric Muscle Strength
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Six Minute Walk Test
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
Six Minute Walk Test
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
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.
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.
Secondary Outcome Measures
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%.
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%.
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.
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.
Fall Risk
Fall risk will be quantified by using Biodex balance System
Fall Risk
Fall risk will be quantified by using Biodex balance System
Full Information
NCT ID
NCT04423887
First Posted
June 5, 2020
Last Updated
December 7, 2020
Sponsor
Foundation University Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT04423887
Brief Title
Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis
Official Title
Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Title
Creatine Supplementation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lower Extremity Resistance Exercise Training
Other Intervention Name(s)
Lower Extremity Strength Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Home Exercise Plan
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Electrotherapy + Heating
Intervention Description
Interferential Current therapy (2P), in combination with heating pad for 20 minutes
Intervention Type
Procedure
Intervention Name(s)
Joint Mobilization
Other Intervention Name(s)
Manual Therapy
Intervention Description
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Supplementation
Intervention Description
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Primary Outcome Measure Information:
Title
Knee Pain: Visual Analogue Scale
Description
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.
Time Frame
2 weeks
Title
Knee Pain: Visual Analogue Scale
Description
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.
Time Frame
4 weeks
Title
Knee Range of Motion
Description
Knee Range of Motion will be quantified by using Gonimeter
Time Frame
2 weeks
Title
Knee Range of Motion
Description
Knee Range of Motion will be quantified by using Gonimeter
Time Frame
4 weeks
Title
Knee Isometric Muscle Strength
Description
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Time Frame
2 weeks
Title
Knee Isometric Muscle Strength
Description
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Time Frame
4 weeks
Title
Six Minute Walk Test
Description
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
Time Frame
2 weeks
Title
Six Minute Walk Test
Description
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
Time Frame
4 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
2 weeks
Title
5 repetition sit to stand test
Description
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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%.
Time Frame
2 weeks
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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%.
Time Frame
4 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
2 weeks
Title
Body Composition
Description
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Time Frame
4 weeks
Title
Fall Risk
Description
Fall risk will be quantified by using Biodex balance System
Time Frame
2 weeks
Title
Fall Risk
Description
Fall risk will be quantified by using Biodex balance System
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Organizational Affiliation
Foundation University Institute of Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences
City
Islamabad
State/Province
Federal
ZIP/Postal Code
45710
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis
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