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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423887
• Other study ID #: FUI/CTR/2020/5
• Status: Completed
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: December 6, 2020

Study information

• Verified date: December 2020
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 6, 2020
• Est. primary completion date: December 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Lower Extremity Resistance Exercise Training
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
• Home Exercise Plan
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

Device:
• Electrotherapy + Heating
Interferential Current therapy (2P), in combination with heating pad for 20 minutes

Procedure:
• Joint Mobilization
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization

Dietary Supplement:
• Creatine Supplementation
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks

Locations

Country	Name	City	State
Pakistan	Foundation University Institute of Rehabilitation Sciences	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Knee Range of Motion	Knee Range of Motion will be quantified by using Gonimeter	2 weeks
Primary	Knee Range of Motion	Knee Range of Motion will be quantified by using Gonimeter	4 weeks
Primary	Knee Isometric Muscle Strength	Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer	2 weeks
Primary	Knee Isometric Muscle Strength	Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer	4 weeks
Primary	Six Minute Walk Test	Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.	2 weeks
Primary	Six Minute Walk Test	Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.	4 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fall Risk	Fall risk will be quantified by using Biodex balance System	2 weeks
Secondary	Fall Risk	Fall risk will be quantified by using Biodex balance System	4 weeks