Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
33 participants
INTERVENTIONAL
2011-05-31
2012-03-31
Brief Summary
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Different exercise types may affect the pain sensitivity differently. It is hypothesized that non-specific exercises (i.e. exercises that does not involve the knee) reduces the processing of pain in the central nervous system (central sensitivity) to knee joint pain in healthy subjects. It is also hypothesized that exercises that involve the knee (i.e. specific knee exercises) reduce the sensitivity of pain receptors in the knee (peripheral sensitivity) in healthy subjects.
Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no exercises). The active interventions include exercises three times per week for 12 weeks. Pain sensitivity and a range of explanatory variables is measured before the interventions, after 4 weeks and after 12 weeks.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Control
No intervention for 12 weeks
No interventions assigned to this group
Knee muscle strengthening exercises
Knee muscle strengthening exercises
Muscle strengthening exercises of the quadriceps and hamstring muscles will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Upper extremity strengthening exercises
Upper extremity strengthening exercises
Muscle strengthening exercises of the upper amrs and shoulder girdle will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Cardiovascular fitness exercises
Cardiovascular fitness exercises
Cardiovascular fitness exercises encompass circuit training including exercises on (but not limited to): ergometer cycles, treadmills (running), and cross-trainers. The exercise intensity is aiming at exercises within 60-85% of maximum heart rate (defined as 220 - age). The heart rate is monitored using a standard heart rate monitor. The exercises will be supervised
Interventions
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Knee muscle strengthening exercises
Muscle strengthening exercises of the quadriceps and hamstring muscles will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Upper extremity strengthening exercises
Muscle strengthening exercises of the upper amrs and shoulder girdle will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
Cardiovascular fitness exercises
Cardiovascular fitness exercises encompass circuit training including exercises on (but not limited to): ergometer cycles, treadmills (running), and cross-trainers. The exercise intensity is aiming at exercises within 60-85% of maximum heart rate (defined as 220 - age). The heart rate is monitored using a standard heart rate monitor. The exercises will be supervised
Eligibility Criteria
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Inclusion Criteria
* Untrained (i.e. less than 2 hours of organised exercise per week in the last 6 months - physical activity related to transportation (e.g. bicycling) is not included)
* Generally healthy according a medical exam at screening, history
* Willing and able to participate in all measurements
* Willing and able to attend all training sessions
* Willing to keep the habitual activity and amount of training constant (ie screening activity and training volume).
* 20 ≤ body mass index (BMI) ≤ 28 kg/m2
* Speak, read and write Danish
Exclusion Criteria
* Current or previous symptoms of autoimmune disease (eg, inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
* Planned surgery during the study period
* Current or former musculoskeletal injuries or illnesses, including but not confined to:
* Ligament Injuries
* Meniscus Injuries
* Osteoarthritis
* Patellofemoral Pain Syndrome
* Backache
* Neck pain
* tendinopathy
* Current or past diagnosis, signs or symptoms of significant cardiovascular disease, including but not limited to:
* Ischemic heart disease
* Arteriosclerosis
* Medical conditions that contraindicate exercise, including but not limited to:
* Chronic or congenital heart disease
* Asthma
* Chronic Obstructive Pulmonary Disease
* Past or current diagnosis, signs or symptoms of significant neurological disease, in-incl. but not limited to:
* Blood clot in brain
* Stroke
* Clinically significant head trauma within the last year
* Peripheral neuropathy
* Epilepsy or seizures
* Impaired balance
* Alcohol or drug abuse within the past 5 years
* Past or current diagnosis, signs or symptoms of major psychiatric disorder
* Regional pain syndromes like fibromyalgia
* Regional pain caused by lumbar nerve root or cervical radiculopathy with or at risk for developing it
18 Years
35 Years
ALL
Yes
Sponsors
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Henning Bliddal
OTHER
Responsible Party
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Henning Bliddal
Professor
Principal Investigators
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Marius Henriksen, PT,PhD
Role: PRINCIPAL_INVESTIGATOR
Senior Researcher
Locations
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The Parker Institute, Frederiksberg University Hospital
Copenhagen, , Denmark
Countries
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References
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Henriksen M, Klokker L, Bartholdy C, Graven-Nielsen T, Bliddal H. The Associations between Pain Sensitivity and Knee Muscle Strength in Healthy Volunteers: A Cross-Sectional Study. Pain Res Treat. 2013;2013:787054. doi: 10.1155/2013/787054. Epub 2013 Sep 17.
Other Identifiers
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10-093704
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
101.01
Identifier Type: -
Identifier Source: org_study_id