- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977374
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to reduce the load of knee osteoarthritis patients in society so that the individual lives a healthy life without getting caught in any form of disability. Knee osteoarthritis is a progressive and degenerative disease of a joint that includes focal cartilage loss, bony hypertrophy, synovial capsule thickening, and changes in structures of periarticular ligaments and peripheral muscles.
There are several techniques used to overcome the individual's pain, for instance, the mobilization of the joint, prolotherapy, and the use of different electrical modalities. meanwhile, an elliptical workout provides a positive result in reducing the progression of overall knee joint and cartilage defects. elliptical training is included in low-impact activities which are proven joint-friendly activities for the better improvement of the knee joint.
This activity works on a similar principle of cyclic compressive loading as occurs in the manual mobilization of the knee joint. This activity brings out the fluid from the synovial membrane on compression and upon decompression, the cartilage reabsorbs the oxygen and nutrients, which crosses the synovial barrier into the synovial fluid through a double diffusion system in the joint. The fluid then reaches the extra-cellular matrix that moves to the multiple layers of chondrocytes for the growth of the cartilage in OA.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Islamabad, Pakistan
- Islamabad Physical Therapy & Rehabilitation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 40- to 65-year-old.
- Diagnosed cases of Grade 1 and 2 Knee OA.
- Healthy and overweight patients will be included. (18.5- 29.5)
Exclusion Criteria:
- Acute musculoskeletal injury.
- Low back pain and Sciatica.
- Hip and ankle pathology.
- Acute infection, fever.
- The patient taking supplements and medications.
- Any knee deformity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: elliptical training group.
In this group, Ultrasound 1MHz, 1.5W/cm2 7 mins, knee isometrics, and open chain activities.
static stretching of the lower limbs will be given 10 reps each and held for 10 secs. 5 mins of warm-up activity on elliptical training will be given prior to the treatment group.
then 3 mins of training with a set pace of 120 strides/min will start, then after 7 weeks, the timings will be increased to 5 mins.
The base check-up will be conducted during 7 weeks and at the end of 12 weeks.
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Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
Other Names:
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Other: Conventional treatment group
Static stretching of the lower limbs as mentioned above, Ultrasound 1MHz 1.5W/cm2 7min, knee isometrics, open chain activities, anterior-posterior Maitland knee mobilizations grade 1 and 2, and home care plan.
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Static stretchings of the lower limb, Ultrasound 1 MHz 1.5W/cm2 7 mins, knee isometrics, open chain activities, knee mobilizations grade 1 and 2, and home care plan.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knee joint pain.
Time Frame: Baseline, 6th week and 12th week.
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Pain is measured through KOOS questionnaire, which is the part of the KOOS and it has 9 items to identify pain scoring.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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Baseline, 6th week and 12th week.
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Knee joint X-rays.
Time Frame: Baseline, 6th week and 12th week.
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From the X-rays we will measure the medial and lateral knee joint space width through Radiant software.
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Baseline, 6th week and 12th week.
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Knee joint stiffness and symptoms.
Time Frame: Baseline, 6th week and 12th week.
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This is the part of KOOS questinnaire, it involves 5 items of symptoms and 2 items of stiffnss to rule out knee joint symptoms and stiffness.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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Baseline, 6th week and 12th week.
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Activities of daily livings impact on knee joint
Time Frame: Baseline, 6th week and 12th week.
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This is also the part of KOOS questionnaire, it includes 17 items to find out the scoring.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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Baseline, 6th week and 12th week.
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Sports activity impact on knee joint
Time Frame: Baseline, 6th week and 12th week.
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We can find the sports scoring through KOOS questionnaire, it embroils 5 items.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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Baseline, 6th week and 12th week.
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Quality of life impact on knee joint
Time Frame: Baseline, 6th week and 12th week.
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This one is also the part of KOOS questionnaire. it contain 4 items for scoring.
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
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Baseline, 6th week and 12th week.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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