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| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
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Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Six-week exercise including stretching, strengthening, endurance and gait modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Comprehensive exercise program including strengthening, stretching, gait modification etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System | External knee moment in the frontal plane during early stance phase of walking | At baseline and one week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score | Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome. | At baseline and one week after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siu Ngor Fu, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise | Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System | External knee moment in the frontal plane during early stance phase of walking | Posted | Mean | Standard Deviation | Nm/kg | At baseline and one week after intervention |
|
|
6 weeks since start of exercise program 1 year after finishing the exercise program
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Six-week exercise including stretching, strengthening, endurance and gait modification Exercise: Comprehensive exercise program including strengthening, stretching, gait modification etc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Amy Fu | The Hong Kong Polytechnic University | 8522766 6726 | amy.fu@polyu.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2020 | Feb 24, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2020 | Feb 24, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Tibial Torsion as Assessed by X-ray Imaging |
The angle between tibial and femur in the transverse plane |
| At baseline |
| Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography | Young's modulus by ultrasound elastography | At baseline and one week after intervention |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score | Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and one week after intervention |
|
|
|
| Secondary | Tibial Torsion as Assessed by X-ray Imaging | The angle between tibial and femur in the transverse plane | Not Posted | At baseline | Participants |
| Secondary | Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography | Young's modulus by ultrasound elastography | Not Posted | At baseline and one week after intervention | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D012216 |
| Rheumatic Diseases |