Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01682980|
Recruitment Status : Recruiting
First Posted : September 11, 2012
Last Update Posted : October 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Pain||Other: Strength training Other: Aerobic exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes and Structural Changes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2025|
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.
- Knee-related quality of life [ Time Frame: 1 year ]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 ]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 ]
- Radiographic osteoarthritis progression [ Time Frame: 2 years ]Conventional x-rays will be used to assess radiographic progression of osteoarthritis
- Cartilage morphology measures (MRI) [ Time Frame: 1 year ]MRI techniques including T2 mapping and T1rho sequences.
- Isokinetic muscle strength [ Time Frame: 1 year ]
- Maximal oxygen consumption (VO2max) [ Time Frame: 1 year ]
- Self-efficacy for pain (ASES) [ Time Frame: 1 year ]
- Total knee replacement [ Time Frame: 5 years ]We will register continuously numbers of total knee replacements during the follow-up years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682980
|Contact: Britt Elin Øiestad, PhD||+4792803089||Britt-Elin.Oiestad@hioa.no|
|Contact: May Arna Risberg, PhDfirstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Britt Elin Øiestad, PhD +4792803089 Britt-Elin.Oiestad@hioa.no|
|Principal Investigator: Britt Elin Øiestad, PhD|
|Sub-Investigator: May Arna Risberg, PhD|
|Study Chair:||May Arna Risberg, PhD||Oslo University Hospital|