Osteoarthritis, Knee Clinical Trial
Official title:
Effects of Low Impact Elliptical Training on Knee Osteoarthritis Outcomes.
| NCT number | NCT05977374 |
| Other study ID # | 01238 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 12, 2022 |
| Est. completion date | June 27, 2023 |
| Verified date | July 2023 |
| Source | Riphah International University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This research study is determined to see the effects of low-impact elliptical training on knee osteoarthritis outcomes.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | June 27, 2023 |
| Est. primary completion date | May 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Islamabad Physical Therapy & Rehabilitation Centre | Islamabad |
| Lead Sponsor | Collaborator |
|---|---|
| Riphah International University | Health Education Research Foundation (HERF) |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Knee joint pain. | 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. | Baseline, 6th week and 12th week. | |
| Primary | Knee joint X-rays. | From the X-rays we will measure the medial and lateral knee joint space width through Radiant software. | Baseline, 6th week and 12th week. | |
| Primary | Knee joint stiffness and symptoms. | 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. | Baseline, 6th week and 12th week. | |
| Primary | Activities of daily livings impact on knee joint | 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. | Baseline, 6th week and 12th week. | |
| Primary | Sports activity impact on knee joint | 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. | Baseline, 6th week and 12th week. | |
| Primary | Quality of life impact on knee joint | 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. | Baseline, 6th week and 12th week. |
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