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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|