- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279339
Subjective and Objective Changes in Muscle-stiffness
March 4, 2022 updated by: Steffan Wittrup Christensen, Aalborg University
The Relationship Between Subjective and Objective Changes in Muscle-stiffness
The purpose of this study is to investigate muscle stiffness in relation to delayed on-set muscle soreness following exercise and to investigate how well the change in muscle stiffness correlates with the subjective experienced degree of stiffness.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steffan WM Christensen, PhD
- Phone Number: +45 99408889
- Email: stc@hst.aau.dk
Study Locations
-
-
-
Aalborg, Denmark, 9220
- Recruiting
- Dept. Of Health Science and Technology, Aalborg University
-
Contact:
- Steffan W Christensen, PhD
-
-
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy participants aged 18-80
- Able to speak, read and understand Danish and/or English
Exclusion Criteria:
- Have performed resistance training on a regular basis during the past month
- Experience of delayed onset muscle soreness (DOMS) during the last two weeks leading up to the first test session
- Current use of analgesics
- Any current neurological, musculoskeletal or mental illnesses that could interfere with the results.
- Pregnancy
- Lack of ability to cooperate
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Participants will not perform any exercise
|
|
|
Experimental: Exercise
Participants will perform an exercise recommended for preventing neck and shoulder pain
|
Upper limb exercises using an elastic band.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle stiffness (change) - Shear wave
Time Frame: Day1,Day 2 and Day7
|
Muscle stiffness measured by ultrasound using shear wave elastography
|
Day1,Day 2 and Day7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle stiffness (change) - Self-reported
Time Frame: Day1,Day 2 and Day7
|
Self-reported muscle stiffness: Measured on a NRS scale (0-10), where 0 = not stiff at all, 10 is maximal stiffness
|
Day1,Day 2 and Day7
|
|
Muscle stiffness (change) - Myotonometry
Time Frame: Day1,Day 2 and Day7
|
Muscle stiffness measured by Myotonometry
|
Day1,Day 2 and Day7
|
|
Muscle stiffness (change)- Palpation
Time Frame: Day1,Day 2 and Day7
|
Muscle palpation: Reported using a 5-point Likert: 1 = very low muscle stiffness and 5 = very high muscle stiffness
|
Day1,Day 2 and Day7
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle thickness
Time Frame: Day1,Day 2 and Day7
|
Muscle thickness measured by ultrasound
|
Day1,Day 2 and Day7
|
|
Muscle soreness
Time Frame: Day1,Day 2 and Day7
|
Self-reported muscle soreness: Measured on a NRS scale (0-10), where 0 = not sore at all, 10 is maximal soreness
|
Day1,Day 2 and Day7
|
|
Neck disability
Time Frame: Day1,Day 2 and Day7
|
The NDI is questionnaire investigating neck pain and disability: Scores range from 0 to 50.
Higher score represent worse disability
|
Day1,Day 2 and Day7
|
|
Shoulder disability
Time Frame: Day1,Day 2 and Day7
|
SPADI is a 13-item questionnaire investigating shoulder pain and disability: Scores range from 0 to 130. Higher score represent worse disability
|
Day1,Day 2 and Day7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steffan WM Christensen, PhD, Aalborg University
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 (Actual)
February 21, 2022
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
February 16, 2022
First Submitted That Met QC Criteria
March 4, 2022
First Posted (Actual)
March 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAU031-1004903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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