Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

August 12, 2023 updated by: Wagner Rodrigues Martins, University of Brasilia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 72220-900
        • University of Brasilia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Will received multimodal circuit exercise group.
Other: Multimodal circuit exercise
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,
Active Comparator: Control Group
Will received multidisciplinary lectures on pain and usual care provided by the Basic Health Units.
Other: Multidisciplinary lectures
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 from Baseline at immediately post-intervention
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 from Baseline at immediately post-intervention
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).
Change from Baseline at immediately post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on cardiorespiratory capacity.
Time Frame: Change from Baseline at immediately post-intervention
Will be used the 6-minute walk test.
Change from Baseline at immediately post-intervention
Change on functional mobility
Time Frame: Change from Baseline at immediately post-intervention
Will be used the Time up and go test.
Change from Baseline at immediately post-intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Brasilia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Minas Gerais
Universidade Federal de Goias
Federal University of Tocantins

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UNB11121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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