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Effects of Acute Exercise on Pain and Human Movement (eMOVE)

Primary Purpose

Chronic Musculoskeletal Disease, Chronic Pain, Widespread

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Acute exercise
Sponsored by
Dalarna University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Disease focused on measuring Chronic musculoskeletal pain, Acute exercise, Movement control, Muscle activity

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for participants with chronic pain:

  • Men and women, age 18-67 years,
  • good ability to understand written and verbal information and instruction given in Swedish,
  • chronic (>3 months) musculoskeletal pain or chronic widespread pain.

Inclusion criteria for healthy controls:

  • Men and women, age 18-67 years,
  • good ability to understand written and verbal information and instruction given in Swedish.

Exclusion Criteria:

For participants with chronic pain

  • chronic pain caused by malignancies or systemic diseases, other physical conditions that affects functional abilities and implies use of walking aid in-door,
  • pregnancy after week 12, childbirth within the last 3 months or
  • spinal surgery.

For healthy controls:

  • chronic (>3 months) or acute pain of any cause,
  • other physical conditions that affects functional abilities, and implies use of walking aids in-door,
  • pregnancy after week 12, childbirth in the last 3 months or
  • spinal surgery.

Sites / Locations

  • Dalarna University (LIVI lab)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acute exercise

Rest

Arm Description

Acute exercise (bicycle at stationary cycle).

Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm.

Outcomes

Primary Outcome Measures

Kinematic measures of human movement during functional gait sequences
Objective measures of movement control using sophisticated wearable sensors (accelerometer-based APDM-sensors applied at participants wrists, ankles, chest and head) during walking in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test: participants listens to a recording of a voice that presents random series of digits between 1 to 9 with two seconds apart. The participants will be instructed to respond as quickly and accurately as possible, repeating the digit before the last one in the sequence.). Lumbar trunk rotations (degrees) will specifically be evaluated while many other kinematic variables (walking speed, step length, step width etc) will be analyzed with factor analyz-es to reduce data variables to relevant data domains, such as gait stability. Data will be aggregated as means and variances.
Muscle activity
Evaluation of back muscle activity using electromyographics (EMG) during walking as in outcome 1, i.e. in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test). Participants will be instrumented with surface-EMG (Delsys Incorporated, Massachusetts) electrodes applied bilateral at participants back and neck muscles. Back and neck spatial and temporal muscle activity (EMG amplitudes) representing repeated gait cycles will be aggregated to one cycle; factor analyzes may be applied to reduce data variables to relevant data domains. Data will be presented as means and variances.

Secondary Outcome Measures

Self-rated pain using the Visual Analogue Scale (VAS scale).
Self-rated pain will be measured using a horizontal 10-cm line "Visual Analogue Scale" (VAS) with the statement 'no pain at all' at the extreme left-hand end, and 'the worst possible pain' or 'unbearable' at the right-hand extreme.

Full Information

First Posted
December 12, 2018
Last Updated
September 8, 2021
Sponsor
Dalarna University
Collaborators
Dalarna County Council, Sweden, Swedish Council for Working Life and Social Research, Karolinska Institutet, Swedish Armed Forces
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1. Study Identification

Unique Protocol Identification Number
NCT03882333
Brief Title
Effects of Acute Exercise on Pain and Human Movement
Acronym
eMOVE
Official Title
Effects of Acute Exercise on Pain and Human Movement - a Randomised Controlled Study in Patients With Chronic Pain and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalarna University
Collaborators
Dalarna County Council, Sweden, Swedish Council for Working Life and Social Research, Karolinska Institutet, Swedish Armed Forces

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement con-trol between patients with chronic musculoskeletal pain compared to healthy controls.
Detailed Description
The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement control between patients with chronic musculoskeletal pain compared to healthy controls. All tests will be conducted at Dalarna University. After the initial baseline tests, participants will be randomised to either acute exercise intervention group or to a control group not performing any intervention groups (both patients and controls will be randomised to intervention or control). If randomised to the control group, participants rests corresponding to the time it takes to perform the intervention (30 min), and then preform the post-intervention tests similar as the intervention group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Disease, Chronic Pain, Widespread
Keywords
Chronic musculoskeletal pain, Acute exercise, Movement control, Muscle activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised controlled study in patients with chronic pain and healthy controls
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute exercise
Arm Type
Experimental
Arm Description
Acute exercise (bicycle at stationary cycle).
Arm Title
Rest
Arm Type
No Intervention
Arm Description
Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm.
Intervention Type
Other
Intervention Name(s)
Acute exercise
Intervention Description
30 min acute exercise (bicycle at stationary cycle)
Primary Outcome Measure Information:
Title
Kinematic measures of human movement during functional gait sequences
Description
Objective measures of movement control using sophisticated wearable sensors (accelerometer-based APDM-sensors applied at participants wrists, ankles, chest and head) during walking in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test: participants listens to a recording of a voice that presents random series of digits between 1 to 9 with two seconds apart. The participants will be instructed to respond as quickly and accurately as possible, repeating the digit before the last one in the sequence.). Lumbar trunk rotations (degrees) will specifically be evaluated while many other kinematic variables (walking speed, step length, step width etc) will be analyzed with factor analyz-es to reduce data variables to relevant data domains, such as gait stability. Data will be aggregated as means and variances.
Time Frame
30 minutes (before and after the acute exercise intervention)
Title
Muscle activity
Description
Evaluation of back muscle activity using electromyographics (EMG) during walking as in outcome 1, i.e. in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test). Participants will be instrumented with surface-EMG (Delsys Incorporated, Massachusetts) electrodes applied bilateral at participants back and neck muscles. Back and neck spatial and temporal muscle activity (EMG amplitudes) representing repeated gait cycles will be aggregated to one cycle; factor analyzes may be applied to reduce data variables to relevant data domains. Data will be presented as means and variances.
Time Frame
30 minutes (before and after the acute exercise intervention)
Secondary Outcome Measure Information:
Title
Self-rated pain using the Visual Analogue Scale (VAS scale).
Description
Self-rated pain will be measured using a horizontal 10-cm line "Visual Analogue Scale" (VAS) with the statement 'no pain at all' at the extreme left-hand end, and 'the worst possible pain' or 'unbearable' at the right-hand extreme.
Time Frame
30 minutes (before and after the acute exercise intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for participants with chronic pain: Men and women, age 18-67 years, good ability to understand written and verbal information and instruction given in Swedish, chronic (>3 months) musculoskeletal pain or chronic widespread pain. Inclusion criteria for healthy controls: Men and women, age 18-67 years, good ability to understand written and verbal information and instruction given in Swedish. Exclusion Criteria: For participants with chronic pain chronic pain caused by malignancies or systemic diseases, other physical conditions that affects functional abilities and implies use of walking aid in-door, pregnancy after week 12, childbirth within the last 3 months or spinal surgery. For healthy controls: chronic (>3 months) or acute pain of any cause, other physical conditions that affects functional abilities, and implies use of walking aids in-door, pregnancy after week 12, childbirth in the last 3 months or spinal surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn BA Äng, Assoc. Prof.
Organizational Affiliation
Dalarna University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalarna University (LIVI lab)
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79131
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Acute Exercise on Pain and Human Movement

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