- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315934
Comparing the Effects of Upper and Lower Body Aerobic Exercise on Pain in Individuals With Chronic Knee Pain
A Comparison of the Effects of Upper Versus Lower Body Aerobic Exercise on the Experience of Pain in Individuals With Chronic Knee Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pain has a multifaceted nature encompassing peripheral drivers (i.e. loading), peripheral and central nervous systems (peripheral and central sensitisation) and cognition (i.e. fear). Most recently, evidence supports that chronic pain in OA may cause alterations to the peripheral and central nervous systems. Despite this, current research has mainly targeted peripheral drivers (usually weight reduction) and cognition (educational programmes) with results highlighting that such methods are not always effective in reducing pain. It would be useful to provide a wider range of choice when prescribing exercise for OA for those which the current prescription is ineffective or un-desirable.
Acutely, both localised and generalised exercise involving the knee joint in individuals with KOA is known to increase symptomatic pain in some. However, research suggests that diverting exercise away from the affected joint may improve pain perception and pain experience in a subset of individuals by targeting cognition (attention away from the joint) and alleviating peripheral drivers of pain (reduced loading) while still presenting systemic physiological benefits that come with acute aerobic exercise which target peripheral and central sensitisation. Currently, there is only one study (Burrows et al, 2014) which has compared the effects of acute upper vs. lower body exercise on pain perception in KOA patients and this was employing resistance exercise. Although this study found positive effects of upper body exercise on pain, this pain was experimentally induced, and symptomatic pain was not measured.
The investigators aim is to determine the effects of a single bout of upper body aerobic exercise on experimentally induced and symptomatic pain in individuals with chronic knee pain in comparison with lower body aerobic exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bath, United Kingdom, BA27AY
- University of Bath
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥45 years
- Male or female
- Knee pain for ≥3 months
- Activity related joint pain
- No joint related morning stiffness, or morning stiffness lasting less than 30 minutes.
Exclusion Criteria:
- Specific joint injury within the last 6 months
- Inability to undertake cycling exercise
- Use of anti-inflammatory medication
- Smoker (or having quit <6 months ago)
- Osteoarthritis at any upper body sites that would affect ability to complete arm-cycling exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Upper Body Aerobic Exercise
Participants will perform 30 minutes of arm-crank cycling at a moderate exercise intensity based off the participants perceived RPE13
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Participants will perform 30 minutes of continuous exercise on the arm-crank ergometer.
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Experimental: Lower Body Aerobic Exercise
Participants will perform 30 minutes of static cycling at a moderate exercise intensity based off the participants perceived RPE13
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Participants will perform 30 minutes of continuous exercise on the cycle ergometer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Symptomatic Pain
Time Frame: Immediately pre and immediately-post exercise
|
Change in symptomatic pain measured via Visual Analogue Scale (VAS) from pre- to post-exercise on a 0-10 scale where 0 is no pain at all and 10 is the worst pain imaginable
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Immediately pre and immediately-post exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute Experimental Pain
Time Frame: Immediately pre and immediately-post exercise
|
Change in experimental pain via Pressure pain threshold and Mechanical detection threshold from pre- to post- exercise
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Immediately pre and immediately-post exercise
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Follow up Symptomatic Pain
Time Frame: 1-7 days post exercise
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Average symptomatic pain in the 7 days following each trial visit measured on a 0-10 Visual Analogue Scale (VAS) where 0 indicates no pain at all and 10 indicates worst pain imaginable
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1-7 days post exercise
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EP 18/19 088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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