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

NCT04423887 | Completed

• 1 other identifier: FUI/CTR/2020/5
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Knee Range of Motion

  Knee Range of Motion will be quantified by using Gonimeter

  2 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

  2 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, walking distance and walking speed.

  2 weeks

• Six Minute Walk Test

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

  4 weeks

• 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

• 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 Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2 weeks

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  4 weeks

• Body Composition

  2 weeks

• Body Composition

  4 weeks

• Fall Risk

  2 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Other: Lower Extremity Resistance Exercise Training; Other: Home Exercise Plan; Device: Electrotherapy + Heating; Procedure: Joint Mobilization

Creatine Supplementation

EXPERIMENTAL

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

Interventions

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

Also known as: Lower Extremity Strength Training

Control; Creatine Supplementation

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

Control; Creatine Supplementation

Electrotherapy + Heating DEVICE

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

Control; Creatine Supplementation

Joint Mobilization PROCEDURE

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

Also known as: Manual Therapy

Control; Creatine Supplementation

Creatine Supplementation DIETARY_SUPPLEMENT

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

Creatine Supplementation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences

Islamabad, Federal, 45710, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electric Stimulation Therapy; Musculoskeletal Manipulations; Creatine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Complementary Therapies; Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Muhammad Osama, PhD*

  Foundation University Institute of Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• 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: June 10, 2020
• Primary Completion: December 6, 2020
• Study Completion: December 6, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

PA (1)