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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
Sponsor:
Collaborators:
University Hospital, Akershus
Oslo Metropolitan University
Information provided by (Responsible Party):
Britt Elin Øiestad, Oslo and Akershus University College of Applied Sciences

Tracking Information
First Submitted Date  ICMJE September 7, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date September 16, 2019
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
Knee pain [ Time Frame: 1 year ]
Primary outcome for the RCT will be the pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale).
Change History Complete list of historical versions of study NCT01682980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • Function [ Time Frame: 1 year ]
    The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, ADL, function in sports and recreation and knee-related (QOL).
  • Health-related quality of life [ Time Frame: 2 years ]
  • Radiographic osteoarthritis progression [ Time Frame: 2 years ]
    Conventional x-rays will be used to assess radiographic progression of osteoarthritis
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2019)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: September 10, 2012)
  • 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 ]
 
Descriptive Information
Brief Title  ICMJE Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis
Official Title  ICMJE Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.
Brief Summary 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Strength training
  • 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).
    Intervention: Other: Aerobic exercise
  • No Intervention: Control group
    The control group will do as usual.
Publications * Øiestad BE, Østerås N, Frobell R, Grotle M, Brøgger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
207
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2012)
198
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women and men aged 35-70 years
  • Clinical knee OA according to the American College of Rheumatology Clinical Criteria
  • Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

  • Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
  • Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
  • Known coronary heart diseases or cancer
  • Body mass index > 35
  • Scheduled for surgery in any joint
  • Known mental or psychologic diseases
  • Known drug abuse
  • Persons who already perform sports related moderate physical activity more than two times a week
  • Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department)
  • Not speaking Norwegian language
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Britt Elin Øiestad, PhD +4792803089 brielo@oslomet.no
Contact: May Arna Risberg, PhD m.a.risberg@nih.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682980
Other Study ID Numbers  ICMJE 2012/334
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Britt Elin Øiestad, Oslo and Akershus University College of Applied Sciences
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • University Hospital, Akershus
  • Oslo Metropolitan University
Investigators  ICMJE
Study Chair: May Arna Risberg, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP