Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
1 other identifier
interventional
36
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 9, 2020
June 1, 2020
10 months
June 5, 2020
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 COMPARATORCreatine Supplementation
EXPERIMENTALGlucoseamine/ Chondritin Sulfate Supplementation
EXPERIMENTALInterventions
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)
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)
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
1. Tibio-femoral Anterior Glide 2. Tibio-femoral Posterior Glide 3. Patellofemoral Joint Mobilization
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)
Eligibility Criteria
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
- Foundation University Islamabadlead
- Isra Universitycollaborator
Study Sites (1)
Foundation University Institute of Rehabilitation Sciences
Islamabad, Federal, 45710, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Osama, PhD*
Foundation University Institute of Rehabilitation Sciences
Central Study Contacts
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