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| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
| Oslo Metropolitan University | OTHER |
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The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain, and physical function in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises and one group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.
The trial aimed to recruit 207 study participants randomly allocated to three arms. The participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the Kellgren and Lawrence radiographic classification system, and they had to have knee pain most of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with other serious comorbidities or self-reported BMI >35 were included.
The interventions consisted of structured strength training program over 12-14 weeks, and a structured stationary cycling program for 12-14 weeks.
Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up. Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen consumption at the 4-month and 1 year follow-up, and over time (1-year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength training | Experimental | The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks. |
|
| Aerobic exercise | Experimental | The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 75% of maximal heart rate (calculated with formula for maximal heart rate reserve). |
|
| Control group | No Intervention | The control group will do as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength training | Other | The strength training will be delivered 2-3 times per week for 12 weeks, 5-8 repetitions maximum in 3 series. The patients must warm up 5 minutes on an ergometer cycle. The following muscle groups will be trained: Quadriceps and hamstrings, hip muscles (abductors and extensors), calf muscles. A home exercise program will be delivered including one leg exercises and balance exercises. Progression will follow a 2+ principle. For instance, when the study participant is able to perform 2 more repetitions, more loads are required. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee-related quality of life | Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, activities of daily living (ADL), function in sports and recreation and knee-related quality of life (QOL). Each scale goes from 0-100, 0 indicating worse function and 100 representing normal function. | 4 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Isokinetic muscle strength | Isokinetic muscle strength will be measured in a Biodex6000 machine. The participants sit in a standardised position and flex/extend their knees at 60 degrees/second. The peak torque value of the five repetitions is recorded. | 4 months and 1 year |
| Maximal oxygen consumption (VO2max) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| May Arna Risberg, PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38803266 | Derived | Killingmo RM, Oiestad BE, Risberg MA, Maas E, Grotle M. Cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with knee osteoarthritis: secondary results from a multiarm randomised controlled trial in Norway. BMJ Open. 2024 May 23;14(5):e079704. doi: 10.1136/bmjopen-2023-079704. | |
| 37684597 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Aug 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Aerobic exercise | Other | The aerobic exercise program include ergometer cycling for at least 45 minutes 2-3 times a week on 75-80% of max heart rate will be required. |
|
| Health-related quality of life | Euro Quality of life 5 dimensions 5 level (EQ-5D-5L) will be used to measure health related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EuroQol (EQ) Visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles. | 4 months and 1 year |
| Radiographic osteoarthritis progression | Conventional x-rays will be used to assess radiographic progression of osteoarthritis | 2 years |
VO2max is measured using an incremental ramp test procedure on a stationary bike, designed to achieve supramaximal workloads within ~4-6 min. The workload was increased by 25 watts every 30 second to total exhaustion. |
| 4 months and 1 year |
| Self-efficacy for pain | Arthritis self-efficacy scale (ASES) was included to measure self-efficacy for pain. A modified version of ASES containing 11 questions regarding the patient's certainty to perform various tasks related to pain and symptoms, where each item is rated from 1 (very uncertain) to 5 (very certain) was used. | 4 months and 1 year |
| Total knee replacement | We will register continuously numbers of total knee replacements during the follow-up years. | 5 years |
| Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x. |
| 24028201 | Derived | Oiestad BE, Osteras N, Frobell R, Grotle M, Brogger H, Risberg MA. Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2013 Sep 12;14:266. doi: 10.1186/1471-2474-14-266. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |