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Subjective and Objective Changes in Muscle-stiffness

Primary Purpose

Healthy, Muscle Soreness

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional diagnostic trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dept. Of Health Science and Technology, Aalborg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise

Arm Description

Participants will not perform any exercise

Participants will perform an exercise recommended for preventing neck and shoulder pain

Outcomes

Primary Outcome Measures

Muscle stiffness (change) - Shear wave

Muscle stiffness measured by ultrasound using shear wave elastography

Secondary Outcome Measures

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

Muscle stiffness (change) - Myotonometry

Muscle stiffness measured by Myotonometry

Muscle stiffness (change)- Palpation

Muscle palpation: Reported using a 5-point Likert: 1 = very low muscle stiffness and 5 = very high muscle stiffness

Full Information

NCT ID

NCT05279339

First Posted

February 16, 2022

Last Updated

March 4, 2022

Sponsor

Aalborg University

1. Study Identification

Unique Protocol Identification Number

NCT05279339

Brief Title

Subjective and Objective Changes in Muscle-stiffness

Official Title

The Relationship Between Subjective and Objective Changes in Muscle-stiffness

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 21, 2022 (Actual)

Primary Completion Date

May 31, 2023 (Anticipated)

Study Completion Date

July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Muscle Soreness

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants will not perform any exercise

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Participants will perform an exercise recommended for preventing neck and shoulder pain

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Upper limb exercises using an elastic band.

Primary Outcome Measure Information:

Title

Muscle stiffness (change) - Shear wave

Description

Muscle stiffness measured by ultrasound using shear wave elastography

Time Frame

Day1,Day 2 and Day7

Secondary Outcome Measure Information:

Title

Muscle stiffness (change) - Self-reported

Description

Self-reported muscle stiffness: Measured on a NRS scale (0-10), where 0 = not stiff at all, 10 is maximal stiffness

Time Frame

Day1,Day 2 and Day7

Title

Muscle stiffness (change) - Myotonometry

Description

Muscle stiffness measured by Myotonometry

Time Frame

Day1,Day 2 and Day7

Title

Muscle stiffness (change)- Palpation

Description

Muscle palpation: Reported using a 5-point Likert: 1 = very low muscle stiffness and 5 = very high muscle stiffness

Time Frame

Day1,Day 2 and Day7

Other Pre-specified Outcome Measures:

Title

Muscle thickness

Description

Muscle thickness measured by ultrasound

Time Frame

Day1,Day 2 and Day7

Title

Muscle soreness

Description

Self-reported muscle soreness: Measured on a NRS scale (0-10), where 0 = not sore at all, 10 is maximal soreness

Time Frame

Day1,Day 2 and Day7

Title

Neck disability

Description

The NDI is questionnaire investigating neck pain and disability: Scores range from 0 to 50. Higher score represent worse disability

Time Frame

Day1,Day 2 and Day7

Title

Shoulder disability

Description

SPADI is a 13-item questionnaire investigating shoulder pain and disability: Scores range from 0 to 130. Higher score represent worse disability

Time Frame

Day1,Day 2 and Day7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steffan WM Christensen, PhD

Phone

+45 99408889

stc@hst.aau.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steffan WM Christensen, PhD

Organizational Affiliation

Aalborg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. Of Health Science and Technology, Aalborg University

City

Aalborg

ZIP/Postal Code

9220

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steffan W Christensen, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Subjective and Objective Changes in Muscle-stiffness

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