Clinical trial NCT04423887: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Knee Pain: Visual Analogue Scale
timeFrame: 2 weeks
measure: Knee Pain: Visual Analogue Scale
timeFrame: 4 weeks
measure: Knee Range of Motion
timeFrame: 2 weeks
measure: Knee Range of Motion
timeFrame: 4 weeks
measure: Knee Isometric Muscle Strength
timeFrame: 2 weeks
measure: Knee Isometric Muscle Strength
timeFrame: 4 weeks
measure: Six Minute Walk Test
timeFrame: 2 weeks
measure: Six Minute Walk Test
timeFrame: 4 weeks
measure: 5 repetition sit to stand test
timeFrame: 2 weeks
measure: 5 repetition sit to stand test
timeFrame: 4 weeks
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 weeks
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 4 weeks
measure: Body Composition
timeFrame: 2 weeks
measure: Body Composition
timeFrame: 4 weeks
measure: Fall Risk
timeFrame: 2 weeks
measure: Fall Risk
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences
state: Federal
Study officials:
affiliation: Foundation University Institute of Rehabilitation Sciences
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References: