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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Lower Extremity Resistance Exercise Training; Other: Home Exercise Plan; Device: Electrotherapy + Heating; Procedure: Joint Mobilization; Dietary Supplement: Creatine Supplementation

• Registration Number: NCT04423887
• Lead Sponsor: Foundation University Islamabad

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2020-06-10
• Status Verified: 2020-12
• Primary Completion: 2020-12-06
• Study Completion: 2020-12-06
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Electrotherapy + Heating	-
Creatine Supplementation	Joint Mobilization	-
Creatine Supplementation	Home Exercise Plan	-
Control	Lower Extremity Resistance Exercise Training	-
Control	Home Exercise Plan	-
Creatine Supplementation	Creatine Supplementation	-
Control	Joint Mobilization	-
Creatine Supplementation	Electrotherapy + Heating	-
Creatine Supplementation	Lower Extremity Resistance Exercise Training	-

Primary Outcome Measures

Name	Time	Method
Knee Pain: Visual Analogue Scale	4 weeks	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	4 weeks	Knee Range of Motion will be quantified by using Gonimeter
Knee Isometric Muscle Strength	4 weeks	Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Six Minute Walk Test	4 weeks	Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
5 repetition sit to stand test	4 weeks	Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	4 weeks	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	4 weeks	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	4 weeks	Fall risk will be quantified by using Biodex balance System

Trial Locations

Locations (1)

Foundation University Institute of Rehabilitation Sciences; 🇵🇰 Islamabad, Federal, Pakistan