Knee OsteoarthritisNCT04423432
Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
A study testing Lower Extremity Resistance Exercise Training, Home Exercise Plan and Electrotherapy + Heating in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Lower Extremity Resistance Exercise Training, Home Exercise Plan and Electrotherapy + Heating
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Institute of Rehabilitation Sciences
Islamabad, Federal, 45710
Muhammad Osama, 03325540436, osamadpt@gmail.com
Muhammad Osama, PhD*
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Lower Extremity Resistance Exercise Training, Home Exercise Plan, Electrotherapy + Heating, Joint Mobilization, Creatine Supplementation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity Resistance Exercise TrainingOther
Also called Lower Extremity Strength 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)
Home Exercise PlanOther
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)
Electrotherapy + HeatingDevice
Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
Joint MobilizationProcedure or surgery
Also called Manual Therapy
- Tibio-femoral Anterior Glide
- Tibio-femoral Posterior Glide
- Patellofemoral Joint Mobilization
Creatine SupplementationDietary supplement
Also called Creatine Monohydrate
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
Glucoseamine/ Chondritin Sulfate SupplementationDietary supplement
Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Lower Extremity Resistance Exercise Training; Other: Home Exercise Plan; Device: Electrotherapy + Heating; Procedure: Joint Mobilization |
| Creatine Supplementation | Experimental | Not described Receives: Other: Lower Extremity Resistance Exercise Training; Other: Home Exercise Plan; Device: Electrotherapy + Heating; Procedure: Joint Mobilization; Dietary Supplement: Creatine Supplementation |
| Glucoseamine/ Chondritin Sulfate Supplementation | Experimental | Not described Receives: Other: Lower Extremity Resistance Exercise Training; Other: Home Exercise Plan; Device: Electrotherapy + Heating; Procedure: Joint Mobilization; Dietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain: Numeric Pain Rating Scale
Knee Pain will be quantified by using Numeric Pain Rating Scale
Measured: 4 weeks
Knee Range of Motion
Knee Range of Motion will be quantified by using Gonimeter
Measured: 4 weeks
Knee Isometric Muscle Strength
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Measured: 4 weeks
Six Minute Walk Test
Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 4 weeks
Body Composition
Body Composition will be quantified by using Bioelectrical Impedance
Measured: 4 weeks
Fall Risk
Fall risk will be quantified by using Biodex balance System
Measured: 4 weeks
Postural Stability
Postural Stability will be quantified by using Biodex balance System
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Isra University
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, Foundation University Institute of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423432
- Sponsor's protocol ID
- FUI/CTR/2020/4
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04423432
- Acronym / sponsor ID
- FUI/CTR/2020/4
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Collaborators
- Isra University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Glucoseamine/ Chondritin Sulfate Supplementation | Experimental | Other: Lower Extremity Resistance Exercise Training, Other: Home Exercise Plan, Device: Electrotherapy + Heating, Procedure: Joint Mobilization, Dietary Supplement: Glucoseamine/ Chondritin Sulfate Supplementation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Extremity Resistance Exercise TrainingAlso: Lower Extremity Strength Training3 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) | Other | Control, Creatine Supplementation, Glucoseamine/ Chondritin Sulfate Supplementation |
| Home Exercise Plan2 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) | Other | Control, Creatine Supplementation, Glucoseamine/ Chondritin Sulfate Supplementation |
| Electrotherapy + HeatingIinterferential Current therapy (2P), in combination with heating pad for 20 minutes | Device | Control, Creatine Supplementation, Glucoseamine/ Chondritin Sulfate Supplementation |
| Joint MobilizationAlso: Manual Therapy1. Tibio-femoral Anterior Glide 2. Tibio-femoral Posterior Glide 3. Patellofemoral Joint Mobilization | Procedure or surgery | Control, Creatine Supplementation, Glucoseamine/ Chondritin Sulfate Supplementation |
| Creatine SupplementationAlso: Creatine MonohydrateCreatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks | Dietary supplement | Creatine Supplementation |
| Glucoseamine/ Chondritin Sulfate SupplementationGlucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day) | Dietary supplement | Glucoseamine/ Chondritin Sulfate Supplementation |
Primary outcome
Knee Pain: Numeric Pain Rating Scale
Time frame: 4 weeks
Knee Pain will be quantified by using Numeric Pain Rating Scale
Knee Range of Motion
Time frame: 4 weeks
Knee Range of Motion will be quantified by using Gonimeter
Knee Isometric Muscle Strength
Time frame: 4 weeks
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
Six Minute Walk Test
Time frame: 4 weeks
Six Minute Walk Test will be used to quantify walking related performance fatigability, walkind distance and walking speed.
4 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 4 weeks
Body Composition
Time frame: 4 weeks
Fall Risk
Time frame: 4 weeks
Postural Stability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Osama, PhD* principal investigator
Foundation University Institute of Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Extremity Resistance Exercise Training, Home Exercise Plan and Electrotherapy + Heating in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Osama, PhD* (+923325540436, osamadpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain: Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.