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

September 8, 2021 updated by: Bjorn Ang, Dalarna University

Effects of Acute Exercise on Pain and Human Movement - a Randomised Controlled Study in Patients With Chronic Pain and Healthy Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

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 Locations

  • Sweden
    • Dalarna
      • Falun, Dalarna, Sweden, 79131
        • Dalarna University (LIVI lab)

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 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute exercise
Acute exercise (bicycle at stationary cycle).
Other: Acute exercise
30 min acute exercise (bicycle at stationary cycle)
No Intervention: Rest
Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic measures of human movement during functional gait sequences
Time Frame: 30 minutes (before and after the acute exercise intervention)
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.
30 minutes (before and after the acute exercise intervention)
Muscle activity
Time Frame: 30 minutes (before and after the acute exercise intervention)
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.
30 minutes (before and after the acute exercise intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated pain using the Visual Analogue Scale (VAS scale).
Time Frame: 30 minutes (before and after the acute exercise intervention)
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.
30 minutes (before and after the acute exercise intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalarna University

Collaborators

Karolinska Institutet
Swedish Council for Working Life and Social Research
Dalarna County Council, Sweden
Swedish Armed Forces

Investigators

  • Principal Investigator: Björn BA Äng, Assoc. Prof., Dalarna University

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.

General Publications

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)

December 12, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dalarna University 2017-00177

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

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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