Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis
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,physical function and the morphology of the cartilage in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable amount of people worldwide. The randomized controlled trial will involve one intervention group delivered strength exercises compared to another intervention 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes and Structural Changes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.|
- Knee-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale).
- Knee function [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 (QOL).
- Health-related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Radiographic osteoarthritis progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]Conventional x-rays will be used to assess radiographic progression of osteoarthritis
- Cartilage morphology measures (MRI) [ Time Frame: 1 year ] [ Designated as safety issue: No ]MRI techniques including T2 mapping and T1rho sequences.
- Isokinetic muscle strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Maximal oxygen consumption (VO2max) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Self-efficacy for pain (ASES) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Total knee replacement [ Time Frame: 5 years ] [ Designated as safety issue: No ]We will register continuously numbers of total knee replacements during the follow-up years.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2025|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Strength training
The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.
Other: Strength training
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.
Experimental: Aerobic exercise
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).
Other: Aerobic exercise
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.
No Intervention: Control group
The control group will do as usual.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682980
|Contact: Britt Elin Øiestad, PhD||+4792803089||Britt.E.Oiestad@nimi.no|
|Contact: May Arna Risberg, PhDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Britt Elin Øiestad, PhD +4792803089 Britt.E.Oiestad@nimi.no|
|Principal Investigator: Britt Elin Øiestad, PhD|
|Sub-Investigator: May Arna Risberg, PhD|
|Study Chair:||May Arna Risberg, PhD||Oslo University Hospital|