Musculoskeletal PainNCT04719130
Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults
A study testing Multimodal circuit exercise and Multidisciplinary lectures in people with Musculoskeletal Pain and Chronic Pain, run by University of Brasilia at 1 site in Brazil.
Trial summary
Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Musculoskeletal Pain, Chronic Pain
- What is being tested?
- Multimodal circuit exercise and Multidisciplinary lectures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2021to 25 Apr 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects from both sexes;
- Aged 60 or higher;
- Had a history of chronic pain in at least one synovial joint for more than three months.
Who cannot join
- Participants with some types of co-morbidities that may interfere with the research parameters, such as a history of stroke, stenosis of the spinal canal, severe heart disease, fibromyalgia, rheumatoid arthritis;
- Participants who presented a level of pain between 7 and 10 points on the Numeric Rate Scale (NRS) in any body location;
- Participants being under psychiatric treatment with sensory deficits (visual, auditory and intellectual)
- Participants performing any supervised and structured exercise at the moment of study enrollment or six months before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol
Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.
Read the detailed description
This is a randomized parallel study (two arms) with blinded outcome assessments. The participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to Basic Health Units. The sample size estimation indicated 164 participants. Participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): Experimental Group (multimodal circuit exercise) or Control Group (cycle of multidisciplinary lectures on pain ). The primary outcomes are global chronic pain intensity and global functional disability scores. The secondary outcomes are functional mobility and cardiorespiratory capacity. All analyses will be processed using the RStudio software. The differences will be considered statistically significant when a 2-tailed p-value is less than 5% (p < 0.05). The statistical analysis will follow the intention to treat. Discussion: This study will discuss the effects of multimodal circuit exercise on global chronic pain intensity and global body functional disability scores. The hypothesize is that multimodal exercises will reduce musculoskeletal chronic pain and disability in older adults to the same extent as traditional supervised and structured exercises.
- Conditions
- Musculoskeletal Pain, Chronic Pain
- Being tested
- Multimodal circuit exercise, Multidisciplinary lectures
- Keywords
- Exercise Therapy, Multimodal exercise
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal circuit exerciseOther
A structured and supervised multimodal exercise circuit twice a week, under 12 weeks program. The circuit workout program consists of 8 exercises, divided into motor coordination, balance, strength, and aerobic exercises. The exercises will be employed in a reserved room inside of the Basic Health Units. The sessions of exercises will last approximately 50 minutes,
Multidisciplinary lecturesOther
Multidisciplinary lectures on pain and usual care provided by the Basic Health Units. A cycle of multidisciplinary lectures on pain will be offered by professionals in physical education, nursing, physiotherapy, medicine, psychology and social work that will take place in the Basic Health Units every 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Will received multimodal circuit exercise group. Receives: Other: Multimodal circuit exercise |
| Control Group | Active comparator | Will received multidisciplinary lectures on pain and usual care provided by the Basic Health Units. Receives: Other: Multidisciplinary lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on pain intensity.
Will be used the Brief Pain Inventory (BPI). The Brief Pain Inventory (BPI) [32, 33]- a multidimensional, easily used questionnaire, aiming to diagnose a patient's chronic pain during the last 24 hours, categorized into 11 questions, scaled from 0 to 10, in which 10 indicates "worst pain imaginable".
Measured: Change from Baseline at immediately post-intervention
Change on disability.
Will be used the Independence Index in Activities of Daily Living (Katz Index - KI). The total KI score is in the range 0 to 6, whose score 6 represents an independent patient and 0 indicates a highly dependent patient.
Measured: Change from Baseline at immediately post-intervention
Change on pain intensity.
Will be used the Numeric Rating Scale. It is a subjective procedure, widely used due to its reliability, as the patients classify their pain at the moment within a scale from 0 (no pain at all) to 10 (worst pain imaginable).
Measured: Change from Baseline at immediately post-intervention
Secondary outcomes (2)
Change on cardiorespiratory capacity.
Will be used the 6-minute walk test.
Measured: Change from Baseline at immediately post-intervention
Change on functional mobility
Will be used the Time up and go test.
Measured: Change from Baseline at immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start30 Aug 2021
- Primary completion1 Feb 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies 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
- This is a randomized parallel study (two arms) with blinded outcome assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, Federal University of Tocantins, Universidade Federal de Goias
- Responsible party
- Principal investigator, Wagner Rodrigues Martins, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719130
- Sponsor's protocol ID
- UNB11121
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The excel data-base will be shared with all data when the manuscript were submitted to a peer-review process. If published, the paper will be provided all data base by supplementary material.
Publications
Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):160-168. doi: 10.1016/j.berh.2017.10.004. Epub 2017 Nov 4.
PubMed 29224694Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
PubMed 28436583Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
PubMed 25694111Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.
PubMed 17671236Ribeiro DBG, Gentil PRV, Resende RA, Carregaro RL, Fonseca STD, Martins WR. Effectiveness of multimodal circuit exercises for chronic musculoskeletal pain in older adults: A randomized controlled trial protocol. J Frailty Sarcopenia Falls. 2022 Sep 1;7(3):175-182. doi: 10.22540/JFSF-07-175. eCollection 2022 Sep.
PubMed 36119552
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT04719130
- Acronym / sponsor ID
- UNB11121
- Conditions
- Musculoskeletal Pain, Chronic Pain
- Keywords
- Exercise Therapy, Multimodal exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, Federal University of Tocantins, Universidade Federal de Goias
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 22 Jan 2021 (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.
Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.
Detailed description
This is a randomized parallel study (two arms) with blinded outcome assessments. The participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to Basic Health Units. The sample size estimation indicated 164 participants. Participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): Experimental Group (multimodal circuit exercise) or Control Group (cycle of multidisciplinary lectures on pain ). The primary outcomes are global chronic pain intensity and global functional disability scores. The secondary outcomes are functional mobility and cardiorespiratory capacity. All analyses will be processed using the RStudio software. The differences will be considered statistically significant when a 2-tailed p-value is less than 5% (p < 0.05). The statistical analysis will follow the intention to treat. Discussion: This study will discuss the effects of multimodal circuit exercise on global chronic pain intensity and global body functional disability scores. The hypothesize is that multimodal exercises will reduce musculoskeletal chronic pain and disability in older adults to the same extent as traditional supervised and structured exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized parallel study (two arms) with blinded outcome assessments.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Multimodal circuit exerciseWill received multimodal circuit exercise group. |
| Control Group | Active comparator | Other: Multidisciplinary lecturesWill received multidisciplinary lectures on pain and usual care provided by the Basic Health Units. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects from both sexes;
- Aged 60 or higher;
- Had a history of chronic pain in at least one synovial joint for more than three months.
Key exclusion criteria (4 listed)
- Participants with some types of co-morbidities that may interfere with the research parameters, such as a history of stroke, stenosis of the spinal canal, severe heart disease, fibromyalgia, rheumatoid arthritis;
- Participants who presented a level of pain between 7 and 10 points on the Numeric Rate Scale (NRS) in any body location;
- Participants being under psychiatric treatment with sensory deficits (visual, auditory and intellectual)
- Participants performing any supervised and structured exercise at the moment of study enrollment or six months before.
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 |
|---|---|---|
| Multimodal circuit exerciseA structured and supervised multimodal exercise circuit twice a week, under 12 weeks program. The circuit workout program consists of 8 exercises, divided into motor coordination, balance, strength, and aerobic exercises. The exercises will be employed in a reserved room inside of the Basic Health Units. The sessions of exercises will last approximately 50 minutes, | Other | Experimental Group |
| Multidisciplinary lecturesMultidisciplinary lectures on pain and usual care provided by the Basic Health Units. A cycle of multidisciplinary lectures on pain will be offered by professionals in physical education, nursing, physiotherapy, medicine, psychology and social work that will take place in the Basic Health Units every 15 days. | Other | Control Group |
Primary outcome
Change on pain intensity.
Time frame: Change from Baseline at immediately post-intervention
Will be used the Brief Pain Inventory (BPI). The Brief Pain Inventory (BPI) [32, 33]- a multidimensional, easily used questionnaire, aiming to diagnose a patient's chronic pain during the last 24 hours, categorized into 11 questions, scaled from 0 to 10, in which 10 indicates "worst pain imaginable".
Change on disability.
Time frame: Change from Baseline at immediately post-intervention
Will be used the Independence Index in Activities of Daily Living (Katz Index - KI). The total KI score is in the range 0 to 6, whose score 6 represents an independent patient and 0 indicates a highly dependent patient.
Change on pain intensity.
Time frame: Change from Baseline at immediately post-intervention
Will be used the Numeric Rating Scale. It is a subjective procedure, widely used due to its reliability, as the patients classify their pain at the moment within a scale from 0 (no pain at all) to 10 (worst pain imaginable).
2 secondary outcomes
Change on cardiorespiratory capacity.
Time frame: Change from Baseline at immediately post-intervention
Change on functional mobility
Time frame: Change from Baseline at immediately post-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 15 Aug 2023.
- Background: PubMed 29224694Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):160-168. doi: 10.1016/j.berh.2017.10.004. Epub 2017 Nov 4.
- Background: PubMed 28436583Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
- Background: PubMed 25694111Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.
- Background: PubMed 17671236Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.
- Derived from this study: PubMed 36119552Ribeiro DBG, Gentil PRV, Resende RA, Carregaro RL, Fonseca STD, Martins WR. Effectiveness of multimodal circuit exercises for chronic musculoskeletal pain in older adults: A randomized controlled trial protocol. J Frailty Sarcopenia Falls. 2022 Sep 1;7(3):175-182. doi: 10.22540/JFSF-07-175. eCollection 2022 Sep.
- Individual participant dataSharing planned: Yes. The excel data-base will be shared with all data when the manuscript were submitted to a peer-review process. If published, the paper will be provided all data base by supplementary material.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal circuit exercise and Multidisciplinary lectures in people with Musculoskeletal Pain and Chronic Pain, run by University of Brasilia at 1 site in Brazil.
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 3 inclusion and 4 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 15 Aug 2023. 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 Brazil. 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?
Change on pain intensity. (time frame: Change from Baseline at immediately post-intervention). The study lists 3 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 NCT04719130, which also lists 5 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 15 Aug 2023.