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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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Other: Strength training Other: Aerobic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Radiographic osteoarthritis progression [ Time Frame: 2 years ]
    Conventional x-rays will be used to assess radiographic progression of osteoarthritis


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. Total knee replacement [ Time Frame: 5 years ]
    We will register continuously numbers of total knee replacements during the follow-up years.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Britt Elin Øiestad, PhD +4792803089 brielo@oslomet.no
Contact: May Arna Risberg, PhD m.a.risberg@nih.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Britt Elin Øiestad, PhD    +4792803089    brielo@oslomet.no   
Principal Investigator: Britt Elin Øiestad, PhD         
Sub-Investigator: May Arna Risberg, PhD         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Oslo Metropolitan University
Investigators
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Study Chair: May Arna Risberg, PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Britt Elin Øiestad, Principal Investigator, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT01682980     History of Changes
Other Study ID Numbers: 2012/334
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Britt Elin Øiestad, Oslo and Akershus University College of Applied Sciences:
Osteoarthritis
Pain
Exercise
Function
Cartilage quality
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases