Have you or your loved ones been diagnosed with osteoarthritis?

You may be eligible to participate in a osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with osteoarthritis? You may be eligible to participate in a osteoarthritis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Osteoarthritis Clinical Trial in Oslo

NCT01682980 | Interventional

Have you or your loved ones been diagnosed with osteoarthritis?

You may be eligible to participate in a osteoarthritis clinical trial.

Have you or your loved ones been diagnosed with osteoarthritis? You may be eligible to participate in a osteoarthritis clinical trial.

Active not recruiting

Male & Female

35 - 70

Years old

This study is looking to recruit 207 Participants

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.

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Details for the study

Brief Title

Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis

Official Title

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

The trial aimed to recruit 207 study participants randomly allocated to three arms. The
participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the
Kellgren and Lawrence radiographic classification system, and they had to have knee pain most
of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with
other serious comorbidities or self-reported BMI >35 were included.

The interventions consisted of structured strength training program over 12-14 weeks, and a
structured stationary cycling program for 12-14 weeks.

Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up.
Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen
consumption at the 4-month and 1 year follow-up, and over time (1-year).

Treatments and/or Procedures

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.

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Knee-related quality of life

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.

1 year

Secondary

Radiographic osteoarthritis progression

Conventional x-rays will be used to assess radiographic progression of osteoarthritis

2 years

Secondary

Health-related quality of life

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.

4 months and 1 year

Secondary

Knee function

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.

4 months and 1 year

Other

Maximal oxygen consumption (VO2max)

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.

4 months and 1 year

Other

Total knee replacement

We will register continuously numbers of total knee replacements during the follow-up years.

5 years

Other

Self-efficacy for pain

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 months and 1 year

Other

Isokinetic muscle strength

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.

4 months and 1 year

Study 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