Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis

NCT ID: NCT04423432

Last Updated: 2020-06-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to 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 Caregivers

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Lower Extremity Resistance Exercise Training

Intervention Type OTHER

3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)

Home Exercise Plan

Intervention Type OTHER

2 sets of 10 repetitions/day of

1. AROM isolated knee extension and knee flexion
2. Isometric isolated knee extension and knee flexion
3. Isometric terminal knee extension
4. Sit to stand squat

terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

Electrotherapy + Heating

Intervention Type DEVICE

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

Joint Mobilization

Intervention Type PROCEDURE

1. Tibio-femoral Anterior Glide
2. Tibio-femoral Posterior Glide
3. Patellofemoral Joint Mobilization

Creatine Supplementation

Group Type EXPERIMENTAL

Lower Extremity Resistance Exercise Training

Intervention Type OTHER

3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)

Home Exercise Plan

Intervention Type OTHER

2 sets of 10 repetitions/day of

1. AROM isolated knee extension and knee flexion
2. Isometric isolated knee extension and knee flexion
3. Isometric terminal knee extension
4. Sit to stand squat

terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

Electrotherapy + Heating

Intervention Type DEVICE

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

Joint Mobilization

Intervention Type PROCEDURE

1. Tibio-femoral Anterior Glide
2. Tibio-femoral Posterior Glide
3. Patellofemoral Joint Mobilization

Creatine Supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Glucoseamine/ Chondritin Sulfate Supplementation

Group Type EXPERIMENTAL

Lower Extremity Resistance Exercise Training

Intervention Type OTHER

3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)

Home Exercise Plan

Intervention Type OTHER

2 sets of 10 repetitions/day of

1. AROM isolated knee extension and knee flexion
2. Isometric isolated knee extension and knee flexion
3. Isometric terminal knee extension
4. Sit to stand squat

terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

Electrotherapy + Heating

Intervention Type DEVICE

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

Joint Mobilization

Intervention Type PROCEDURE

1. Tibio-femoral Anterior Glide
2. Tibio-femoral Posterior Glide
3. Patellofemoral Joint Mobilization

Glucoseamine/ Chondritin Sulfate Supplementation

Intervention Type DIETARY_SUPPLEMENT

Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)

Interventions

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Lower Extremity Resistance Exercise Training

3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)

Intervention Type OTHER

Home Exercise Plan

2 sets of 10 repetitions/day of

1. AROM isolated knee extension and knee flexion
2. Isometric isolated knee extension and knee flexion
3. Isometric terminal knee extension
4. Sit to stand squat

terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)

Intervention Type OTHER

Electrotherapy + Heating

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

Intervention Type DEVICE

Joint Mobilization

1. Tibio-femoral Anterior Glide
2. Tibio-femoral Posterior Glide
3. 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

Glucoseamine/ Chondritin Sulfate Supplementation

Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lower Extremity Strength Training Manual Therapy Creatine Monohydrate

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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Isra University

OTHER

Sponsor Role collaborator

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 RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Osama, PhD*

Role: CONTACT

+923325540436

Facility Contacts

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Muhammad Osama

Role: primary

03325540436

Other Identifiers

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FUI/CTR/2020/4

Identifier Type: -

Identifier Source: org_study_id

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