Skip to main content
OpenTrials
Completed

NCT Number: NCT04423887

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University Institute of Rehabilitation Sciences

Islamabad, Federal, 45710, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower Extremity Resistance Exercise Training

Other

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

Other names: Lower Extremity Strength Training

Home Exercise Plan

Other

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

Electrotherapy + Heating

Device

Interferential Current therapy (2P), in combination with heating pad for 20 minutes

Joint Mobilization

Procedure

Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization

Other names: Manual Therapy

creatine supplementation

Dietary Supplement

Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks

Primary outcomes

  1. Knee Pain: Visual Analogue Scale

    Time frame: 2 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.

  2. Knee Pain: Visual Analogue Scale

    Time frame: 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.

  3. Knee Range of Motion

    Time frame: 2 weeks

    Knee Range of Motion will be quantified by using Gonimeter

  4. Knee Range of Motion

    Time frame: 4 weeks

    Knee Range of Motion will be quantified by using Gonimeter

  5. Knee Isometric Muscle Strength

    Time frame: 2 weeks

    Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer

  6. Knee Isometric Muscle Strength

    Time frame: 4 weeks

    Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer

  7. Six Minute Walk Test

    Time frame: 2 weeks

    Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.

  8. Six Minute Walk Test

    Time frame: 4 weeks

    Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.

  9. 5 repetition sit to stand test

    Time frame: 2 weeks

    Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.

  10. 5 repetition sit to stand test

    Time frame: 4 weeks

    Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 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%.

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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%.

  3. Body Composition

    Time frame: 2 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.

  4. Body Composition

    Time frame: 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.

  5. Fall Risk

    Time frame: 2 weeks

    Fall risk will be quantified by using Biodex balance System

  6. Fall Risk

    Time frame: 4 weeks

    Fall risk will be quantified by using Biodex balance System

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.