Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

Sponsor
University of Brasilia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04719130
Collaborator
Federal University of Minas Gerais (Other), Federal University of Tocantins (Other), Universidade Federal de Goias (Other)
200
1
2
26
7.7

Study Details

Study Description

Brief Summary

Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.

Condition or Disease Intervention/Treatment Phase
  • Other: Multimodal circuit exercise
  • Other: Multidisciplinary lectures
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized parallel study (two arms) with blinded outcome assessments.This is a randomized parallel study (two arms) with blinded outcome assessments.
Masking:
Single (Outcomes Assessor)
Masking Description:
Another researcher collaborator (blinded) will be carried out the outcomes investigated.
Primary Purpose:
Treatment
Official Title:
Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Change on pain intensity. [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".

  2. Change on disability. [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.

  3. Change on pain intensity. [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).

Secondary Outcome Measures

  1. Change on cardiorespiratory capacity. [Change from Baseline at immediately post-intervention]

    Will be used the 6-minute walk test.

  2. Change on functional mobility [Change from Baseline at immediately post-intervention]

    Will be used the Time up and go test.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Brasilia Brasilia Distrito Federal Brazil 72220-900

Sponsors and Collaborators

  • University of Brasilia
  • Federal University of Minas Gerais
  • Federal University of Tocantins
  • Universidade Federal de Goias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wagner Rodrigues Martins, Professor, University of Brasilia
ClinicalTrials.gov Identifier:
NCT04719130
Other Study ID Numbers:
  • UNB11121
First Posted:
Jan 22, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wagner Rodrigues Martins, Professor, University of Brasilia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021