Chronic Musculoskeletal DiseaseeMOVENCT03882333
Effects of Acute Exercise on Pain and Human Movement
A study testing Acute exercise in people with Chronic Musculoskeletal Disease and Chronic Pain, Widespread, run by Dalarna University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Disease, Chronic Pain, Widespread
- What is being tested?
- Acute exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSweden
- Study dates
- 12 Dec 2018to 30 Jun 2021
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Men and women, age 18-67 years,
- good ability to understand written and verbal information and instruction given in Swedish.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Acute exercise
- Keywords
- Chronic musculoskeletal pain, Acute exercise, Movement control, Muscle activity
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseOther
30 min acute exercise (bicycle at stationary cycle)
| Study group | Role | What they receive |
|---|---|---|
| Acute exercise | Experimental | Acute exercise (bicycle at stationary cycle). Receives: Other: Acute exercise |
| Rest | No intervention | Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes (before and after the acute exercise intervention)
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.
Measured: 30 minutes (before and after the acute exercise intervention)
Secondary outcomes (1)
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.
Measured: 30 minutes (before and after the acute exercise intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start12 Dec 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled study in patients with chronic pain and healthy controls
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna County Council, Sweden, Swedish Council for Working Life and Social Research, Karolinska Institutet, Swedish Armed Forces
- Responsible party
- Principal investigator, Bjorn Ang, Karolinska Institutet
- Investigators
- Björn BA Äng, Assoc. Prof., Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882333
- Sponsor's protocol ID
- Dalarna University 2017-00177
- Acronym
- eMOVE
- Status last verified
- Sep 2021
- First submitted
- 12 Dec 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boecker H, Sprenger T, Spilker ME, Henriksen G, Koppenhoefer M, Wagner KJ, Valet M, Berthele A, Tolle TR. The runner's high: opioidergic mechanisms in the human brain. Cereb Cortex. 2008 Nov;18(11):2523-31. doi: 10.1093/cercor/bhn013. Epub 2008 Feb 21.
PubMed 18296435Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.
PubMed 18594876van den Hoorn W, Bruijn SM, Meijer OG, Hodges PW, van Dieen JH. Mechanical coupling between transverse plane pelvis and thorax rotations during gait is higher in people with low back pain. J Biomech. 2012 Jan 10;45(2):342-7. doi: 10.1016/j.jbiomech.2011.10.024. Epub 2011 Nov 10.
PubMed 22078275Seay JF, Van Emmerik RE, Hamill J. Influence of low back pain status on pelvis-trunk coordination during walking and running. Spine (Phila Pa 1976). 2011 Jul 15;36(16):E1070-9. doi: 10.1097/BRS.0b013e3182015f7c.
PubMed 21304421Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.
PubMed 28528981Bergstrom G, Jensen IB, Bodin L, Linton SJ, Nygren AL, Carlsson SG. Reliability and factor structure of the Multidimensional Pain Inventory--Swedish Language Version (MPI-S). Pain. 1998 Mar;75(1):101-110. doi: 10.1016/S0304-3959(97)00210-8.
PubMed 9539679Tseli E, Boersma K, Stalnacke BM, Enthoven P, Gerdle B, Ang BO, Grooten WJA. Prognostic Factors for Physical Functioning After Multidisciplinary Rehabilitation in Patients With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Feb;35(2):148-173. doi: 10.1097/AJP.0000000000000669.
PubMed 30371517Molander P, Dong HJ, Ang B, Enthoven P, Gerdle B. The role of pain in chronic pain patients' perception of health-related quality of life: a cross-sectional SQRP study of 40,000 patients. Scand J Pain. 2018 Jul 26;18(3):417-429. doi: 10.1515/sjpain-2018-0003.
PubMed 29794267Westergren J, Sjoberg V, Vixner L, Nyberg RG, Moulaee Conradsson D, Monnier A, LoMartire R, Enthoven P, Ang BO. Acute exercise as active inference in chronic musculoskeletal pain, effects on gait kinematics and muscular activity in patients and healthy participants: a study protocol for a randomised controlled laboratory trial. BMJ Open. 2023 May 31;13(5):e069747. doi: 10.1136/bmjopen-2022-069747.
PubMed 37258077
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Exercise on Pain and Human Movement - a Randomised Controlled Study in Patients With Chronic Pain and Healthy Controls
- ClinicalTrials.gov ID
- NCT03882333
- Acronym / sponsor ID
- eMOVE / Dalarna University 2017-00177
- Keywords
- Chronic musculoskeletal pain, Acute exercise, Movement control, Muscle activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Dalarna UniversityUniversity, hospital or other
- Collaborators
- Dalarna County Council, Sweden, Swedish Council for Working Life and Social Research, Karolinska Institutet, Swedish Armed Forces
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Mar 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised controlled study in patients with chronic pain and healthy controls
| Arm | Type | Receives |
|---|---|---|
| Acute exercise | Experimental | Other: Acute exerciseAcute exercise (bicycle at stationary cycle). |
| Rest | No intervention | –Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Men and women, age 18-67 years,
- good ability to understand written and verbal information and instruction given in Swedish.
Key exclusion criteria (9 listed)
- 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.
- chronic (>3 months) or acute pain of any cause,
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 |
|---|---|---|
| Acute exercise30 min acute exercise (bicycle at stationary cycle) | Other | Acute exercise |
Primary outcome
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.
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.
1 secondary outcome
Self-rated pain using the Visual Analogue Scale (VAS scale).
Time frame: 30 minutes (before and after the acute exercise intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 18296435Boecker H, Sprenger T, Spilker ME, Henriksen G, Koppenhoefer M, Wagner KJ, Valet M, Berthele A, Tolle TR. The runner's high: opioidergic mechanisms in the human brain. Cereb Cortex. 2008 Nov;18(11):2523-31. doi: 10.1093/cercor/bhn013. Epub 2008 Feb 21.
- Background: PubMed 18594876Brumagne S, Janssens L, Knapen S, Claeys K, Suuden-Johanson E. Persons with recurrent low back pain exhibit a rigid postural control strategy. Eur Spine J. 2008 Sep;17(9):1177-84. doi: 10.1007/s00586-008-0709-7. Epub 2008 Jul 2.
- Background: PubMed 22078275van den Hoorn W, Bruijn SM, Meijer OG, Hodges PW, van Dieen JH. Mechanical coupling between transverse plane pelvis and thorax rotations during gait is higher in people with low back pain. J Biomech. 2012 Jan 10;45(2):342-7. doi: 10.1016/j.jbiomech.2011.10.024. Epub 2011 Nov 10.
- Background: PubMed 21304421Seay JF, Van Emmerik RE, Hamill J. Influence of low back pain status on pelvis-trunk coordination during walking and running. Spine (Phila Pa 1976). 2011 Jul 15;36(16):E1070-9. doi: 10.1097/BRS.0b013e3182015f7c.
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background: PubMed 28528981Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.
- Background: PubMed 9539679Bergstrom G, Jensen IB, Bodin L, Linton SJ, Nygren AL, Carlsson SG. Reliability and factor structure of the Multidimensional Pain Inventory--Swedish Language Version (MPI-S). Pain. 1998 Mar;75(1):101-110. doi: 10.1016/S0304-3959(97)00210-8.
- Background: PubMed 30371517Tseli E, Boersma K, Stalnacke BM, Enthoven P, Gerdle B, Ang BO, Grooten WJA. Prognostic Factors for Physical Functioning After Multidisciplinary Rehabilitation in Patients With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Feb;35(2):148-173. doi: 10.1097/AJP.0000000000000669.
- Background: PubMed 29794267Molander P, Dong HJ, Ang B, Enthoven P, Gerdle B. The role of pain in chronic pain patients' perception of health-related quality of life: a cross-sectional SQRP study of 40,000 patients. Scand J Pain. 2018 Jul 26;18(3):417-429. doi: 10.1515/sjpain-2018-0003.
- Derived from this study: PubMed 37258077Westergren J, Sjoberg V, Vixner L, Nyberg RG, Moulaee Conradsson D, Monnier A, LoMartire R, Enthoven P, Ang BO. Acute exercise as active inference in chronic musculoskeletal pain, effects on gait kinematics and muscular activity in patients and healthy participants: a study protocol for a randomised controlled laboratory trial. BMJ Open. 2023 May 31;13(5):e069747. doi: 10.1136/bmjopen-2022-069747.
- Individual participant dataSharing planned: No
Related trials for Chronic Musculoskeletal Disease
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Björn BA Äng, Assoc. Prof. principal investigator
Dalarna 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 Acute exercise in people with Chronic Musculoskeletal Disease and Chronic Pain, Widespread, run by Dalarna University at 1 site in Sweden.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic measures of human movement during functional gait sequences (time frame: 30 minutes (before and after the acute exercise intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882333, which also lists 10 linked publications.
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 9 Sep 2021.