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

NCT ID: NCT04423887

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2020-12-06

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Lower Extremity Resistance Exercise Training

Intervention Type 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

Home Exercise Plan

Intervention Type 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

Intervention Type DEVICE

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

Joint Mobilization

Intervention Type PROCEDURE

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

Creatine Supplementation

Group Type EXPERIMENTAL

Lower Extremity Resistance Exercise Training

Intervention Type 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

Home Exercise Plan

Intervention Type 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

Intervention Type DEVICE

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

Joint Mobilization

Intervention Type PROCEDURE

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

Creatine Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Electrotherapy + Heating

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

Intervention Type DEVICE

Joint Mobilization

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

Intervention Type PROCEDURE

Creatine Supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lower Extremity Strength Training Manual Therapy

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Osama, PhD*

Role: PRINCIPAL_INVESTIGATOR

Foundation University Institute of Rehabilitation Sciences

Locations

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Foundation University Institute of Rehabilitation Sciences

Islamabad, Federal, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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FUI/CTR/2020/5

Identifier Type: -

Identifier Source: org_study_id