Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01682980|
Recruitment Status : Recruiting
First Posted : September 11, 2012
Last Update Posted : September 16, 2019
|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 in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2023|
|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). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life.
- 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 quality of life (QOL). Each scale goes from 0-100, 0 indicating worse function and 100 representing normal function.
- Health-related quality of life [ Time Frame: 1 year ]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.
- Radiographic osteoarthritis progression [ Time Frame: 2 years ]Conventional x-rays will be used to assess radiographic progression of osteoarthritis
- Isokinetic muscle strength [ Time Frame: 1 year ]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.
- Maximal oxygen consumption (VO2max) [ Time Frame: 1 year ]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.
- Self-efficacy for pain [ Time Frame: 1 year ]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.
- 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, PhDfirstname.lastname@example.org|
|Contact: May Arna Risberg, PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0407|
|Contact: Britt Elin Øiestad, PhD +4792803089 firstname.lastname@example.org|
|Principal Investigator: Britt Elin Øiestad, PhD|
|Sub-Investigator: May Arna Risberg, PhD|
|Study Chair:||May Arna Risberg, PhD||Oslo University Hospital|