Knee OsteoarthritisNCT04423887
Effects of Creatine Supplementation in Addition to Resistance Exercise Training 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
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. 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
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2020to 6 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
Foundation University Institute of Rehabilitation Sciences
Islamabad, Federal, 45710
About this study
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
- 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
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 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 Isometric knee terminal extension
Electrotherapy + HeatingDevice
Interferential 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
Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Knee Range of Motion
Knee Range of Motion will be quantified by using Gonimeter
Measured: 2 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: 2 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, walking distance and walking speed.
Measured: 2 weeks
Six Minute Walk Test
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.
Measured: 2 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure physical function and quality of life. A greater score on Knee Injury and Osteoarthritis Outcome Score reflects good prognosis and outcome and a lower score shows poor prognosis and outcome. the score for Knee Injury and Osteoarthritis Outcome Score is reported in the form of percentage i.e. 0-100%.
Measured: 4 weeks
Body Composition
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Measured: 2 weeks
Body Composition
Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
Measured: 4 weeks
Fall Risk
Fall risk will be quantified by using Biodex balance System
Measured: 2 weeks
Fall Risk
Fall risk 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 start10 Jun 2020
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
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, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, Foundation University Institute of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423887
- Sponsor's protocol ID
- FUI/CTR/2020/5
- Status last verified
- Dec 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation in Addition to Resistance Exercise Training in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04423887
- Acronym / sponsor ID
- FUI/CTR/2020/5
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| 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 |
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 TrainingTreadmill 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 | Other | Control, Creatine Supplementation |
| Home Exercise Plan2 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 | Other | Control, Creatine Supplementation |
| Electrotherapy + HeatingInterferential Current therapy (2P), in combination with heating pad for 20 minutes | Device | Control, Creatine Supplementation |
| Joint MobilizationAlso: Manual TherapyTibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization | Procedure or surgery | Control, Creatine Supplementation |
| Creatine SupplementationCreatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks | Dietary supplement | Creatine Supplementation |
Primary outcome
Knee Pain: Visual Analogue Scale
Time frame: 2 weeks
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.
Knee Pain: Visual Analogue Scale
Time frame: 4 weeks
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.
Knee Range of Motion
Time frame: 2 weeks
Knee Range of Motion will be quantified by using Gonimeter
Knee Range of Motion
Time frame: 4 weeks
Knee Range of Motion will be quantified by using Gonimeter
Knee Isometric Muscle Strength
Time frame: 2 weeks
Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
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: 2 weeks
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
Six Minute Walk Test
Time frame: 4 weeks
Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
5 repetition sit to stand test
Time frame: 2 weeks
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
5 repetition sit to stand test
Time frame: 4 weeks
Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 4 weeks
Body Composition
Time frame: 2 weeks
Body Composition
Time frame: 4 weeks
Fall Risk
Time frame: 2 weeks
Fall Risk
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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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: finished, as of the sponsor's last update on 9 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain: Visual Analogue Scale (time frame: 2 weeks). The study lists 10 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 Dec 2020.