| Registry | NCT04423887 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 24 (Actual) |
| Sponsor | Foundation University Islamabad (Other) |
| Conditions | Knee Osteoarthritis |
| Interventions | Lower Extremity Resistance Exercise Training, Home Exercise Plan, Electrotherapy + Heating, Joint Mobilization, Creatine Supplementation (Other, device, procedure, dietary supplement) |
| Dates | start 2020-06-10, primary completion 2020-12-06, completion 2020-12-06, first posted 2020-06-09, last updated 2020-12-09 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Knee Osteoarthritis All trials of Lower Extremity Resistance Exercise Training All trials of Home Exercise Plan
-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. 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 | |
- Lower Extremity Resistance Exercise Training (Other), also known as 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 Plan (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 (Device): Interferential Current therapy (2P), in combination with heating pad for 20 minutes
- Joint Mobilization (Procedure), also known as Manual Therapy: Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
- Creatine Supplementation (Dietary supplement): Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
+Outcome measures
Primary outcomes
- Knee Pain: Visual Analogue Scale [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 [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 [2 weeks]: Knee Range of Motion will be quantified by using Gonimeter
- Knee Range of Motion [4 weeks]: Knee Range of Motion will be quantified by using Gonimeter
- Knee Isometric Muscle Strength [2 weeks]: Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
- Knee Isometric Muscle Strength [4 weeks]: Knee Isometric Muscle Strength will be quantified by using Modified Sphygmomanometer Dynamometer
- Six Minute Walk Test [2 weeks]: Six Minute Walk Test will be used to quantify walking related performance fatigability, walking distance and walking speed.
- Six Minute Walk Test [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 [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 [4 weeks]: Time will be measured to perform 5 repetitions of sit to stand activity. Lesser time means a better score.
Secondary outcomes
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [2 weeks]: 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%.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [4 weeks]: 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%.
- Body Composition [2 weeks]: Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
- Body Composition [4 weeks]: Body Composition was measured via bioelectrical impedance analysis. A greater Phase angle reflects better cellular integrity and smaller phase angle reflects poorer cellular integrity.
- Fall Risk [2 weeks]: Fall risk will be quantified by using Biodex balance System
- Fall Risk [4 weeks]: Fall risk will be quantified by using Biodex balance System
+Eligibility
Sex: All, ages: 40 Years to 70 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Foundation University Institute of Rehabilitation Sciences | Islamabad, Federal | Pakistan | |
+Investigators
- Muhammad Osama, PhD*, Principal investigator, Foundation University Institute of Rehabilitation Sciences