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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lower Extremity Resistance Exercise Training
Home Exercise Plan
Electrotherapy + Heating
Joint Mobilization
Creatine Supplementation
Glucoseamine/ Chondritin Sulfate Supplementation
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University Institute of Rehabilitation SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Creatine Supplementation

Glucoseamine/ Chondritin Sulfate Supplementation

Arm Description

Outcomes

Primary Outcome Measures

Knee Pain: Numeric Pain Rating Scale
Knee Pain will be quantified by using Numeric Pain Rating Scale
Knee Range of Motion
Knee Range of Motion will be quantified by using Gonimeter
Knee Isometric Muscle Strength
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Six Minute Walk Test
Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.

Secondary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Body Composition
Body Composition will be quantified by using Bioelectrical Impedance
Fall Risk
Fall risk will be quantified by using Biodex balance System
Postural Stability
Postural Stability will be quantified by using Biodex balance System

Full Information

First Posted
June 5, 2020
Last Updated
June 8, 2020
Sponsor
Foundation University Islamabad
Collaborators
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT04423432
Brief Title
Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
Official Title
Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
Collaborators
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Creatine Supplementation
Arm Type
Experimental
Arm Title
Glucoseamine/ Chondritin Sulfate Supplementation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lower Extremity Resistance Exercise Training
Other Intervention Name(s)
Lower Extremity Strength Training
Intervention Description
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
Intervention Name(s)
Home Exercise Plan
Intervention Description
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 terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)
Intervention Type
Device
Intervention Name(s)
Electrotherapy + Heating
Intervention Description
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
Intervention Type
Procedure
Intervention Name(s)
Joint Mobilization
Other Intervention Name(s)
Manual Therapy
Intervention Description
Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Supplementation
Other Intervention Name(s)
Creatine Monohydrate
Intervention Description
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucoseamine/ Chondritin Sulfate Supplementation
Intervention Description
Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)
Primary Outcome Measure Information:
Title
Knee Pain: Numeric Pain Rating Scale
Description
Knee Pain will be quantified by using Numeric Pain Rating Scale
Time Frame
4 weeks
Title
Knee Range of Motion
Description
Knee Range of Motion will be quantified by using Gonimeter
Time Frame
4 weeks
Title
Knee Isometric Muscle Strength
Description
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Time Frame
4 weeks
Title
Six Minute Walk Test
Description
Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Time Frame
4 weeks
Title
Body Composition
Description
Body Composition will be quantified by using Bioelectrical Impedance
Time Frame
4 weeks
Title
Fall Risk
Description
Fall risk will be quantified by using Biodex balance System
Time Frame
4 weeks
Title
Postural Stability
Description
Postural Stability will be quantified by using Biodex balance System
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Osama, PhD*
Phone
+923325540436
Email
osamadpt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Organizational Affiliation
Foundation University Institute of Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences
City
Islamabad
State/Province
Federal
ZIP/Postal Code
45710
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama
Phone
03325540436
Email
osamadpt@gmail.com
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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