HealthyNCT05279339
Subjective and Objective Changes in Muscle-stiffness
A study testing Exercise in people with Healthy and Muscle Soreness, run by Aalborg University at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Muscle Soreness
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Feb 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged 18-80
- Able to speak, read and understand Danish and/or English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. Of Health Science and Technology, Aalborg University
Aalborg, 9220
Steffan W Christensen, PhD
About this study
Official title: 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.
- Conditions
- Healthy, Muscle Soreness
- Being tested
- Exercise
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Upper limb exercises using an elastic band.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will not perform any exercise |
| Exercise | Experimental | Participants will perform an exercise recommended for preventing neck and shoulder pain Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle stiffness (change) - Shear wave
Muscle stiffness measured by ultrasound using shear wave elastography
Measured: Day1,Day 2 and Day7
Secondary outcomes (3)
Muscle stiffness (change) - Self-reported
Self-reported muscle stiffness: Measured on a NRS scale (0-10), where 0 = not stiff at all, 10 is maximal stiffness
Measured: Day1,Day 2 and Day7
Muscle stiffness (change) - Myotonometry
Muscle stiffness measured by Myotonometry
Measured: Day1,Day 2 and Day7
Muscle stiffness (change)- Palpation
Muscle palpation: Reported using a 5-point Likert: 1 = very low muscle stiffness and 5 = very high muscle stiffness
Measured: Day1,Day 2 and Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start21 Feb 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffan Wittrup Christensen, Aalborg University
- Investigators
- Steffan WM Christensen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279339
- Sponsor's protocol ID
- AAU031-1004903
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Subjective and Objective Changes in Muscle-stiffness
- ClinicalTrials.gov ID
- NCT05279339
- Acronym / sponsor ID
- AAU031-1004903
- Conditions
- Healthy, Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will not perform any exercise |
| Exercise | Experimental | Other: ExerciseParticipants will perform an exercise recommended for preventing neck and shoulder pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants aged 18-80
- Able to speak, read and understand Danish and/or English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseUpper limb exercises using an elastic band. | Other | Exercise |
Primary outcome
Muscle stiffness (change) - Shear wave
Time frame: Day1,Day 2 and Day7
Muscle stiffness measured by ultrasound using shear wave elastography
3 secondary outcomes
Muscle stiffness (change) - Self-reported
Time frame: Day1,Day 2 and Day7
Muscle stiffness (change) - Myotonometry
Time frame: Day1,Day 2 and Day7
Muscle stiffness (change)- Palpation
Time frame: Day1,Day 2 and Day7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffan WM Christensen, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy and Muscle Soreness, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffan WM Christensen, PhD (+45 99408889, stc@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle stiffness (change) - Shear wave (time frame: Day1,Day 2 and Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.