- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346995
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
May 3, 2011 updated by: Frederiksberg University Hospital
The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps.
It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged between 20 to 35 years
- healthy
- untrained (non-regular exercise participation [i.e. < 1 day/week])
Exclusion Criteria:
- symptomatic musculoskeletal diseases
- history of traumatic injuries to muscles, tendons or joints of the lower extremity
- knee joint pain within a month prior to enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Knee Pain
Experimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad
|
Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad
|
|
Active Comparator: Control
non-painful injections of isotonic saline into the infrapatellar fatpad.
|
Injection of isotonic saline into the infrapatellar fat pad
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Isokinetic knee muscle strength
Time Frame: At baseline and after 8 weeks of exercise
|
At baseline and after 8 weeks of exercise
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
One-leg chair rise
Time Frame: At baseline and after 8 weeks of exercise
|
At baseline and after 8 weeks of exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
May 4, 2011
Last Update Submitted That Met QC Criteria
May 3, 2011
Last Verified
February 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 072.07
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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