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Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

Primary Purpose

Musculoskeletal Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multimodal circuit exercise
Multidisciplinary lectures
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Exercise Therapy, Multimodal exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Will received multimodal circuit exercise group.

Will received multidisciplinary lectures on pain and usual care provided by the Basic Health Units.

Outcomes

Primary Outcome Measures

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".
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.
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).

Secondary Outcome Measures

Change on cardiorespiratory capacity.
Will be used the 6-minute walk test.
Change on functional mobility
Will be used the Time up and go test.

Full Information

First Posted
January 12, 2021
Last Updated
August 12, 2023
Sponsor
University of Brasilia
Collaborators
Federal University of Minas Gerais, Federal University of Tocantins, Universidade Federal de Goias
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1. Study Identification

Unique Protocol Identification Number
NCT04719130
Brief Title
Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults
Official Title
Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
Federal University of Minas Gerais, Federal University of Tocantins, Universidade Federal de Goias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Chronic Pain
Keywords
Exercise Therapy, Multimodal exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized parallel study (two arms) with blinded outcome assessments.
Masking
Outcomes Assessor
Masking Description
Another researcher collaborator (blinded) will be carried out the outcomes investigated.
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Will received multimodal circuit exercise group.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Will received multidisciplinary lectures on pain and usual care provided by the Basic Health Units.
Intervention Type
Other
Intervention Name(s)
Multimodal circuit exercise
Intervention Description
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,
Intervention Type
Other
Intervention Name(s)
Multidisciplinary lectures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on pain intensity.
Description
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".
Time Frame
Change from Baseline at immediately post-intervention
Title
Change on disability.
Description
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.
Time Frame
Change from Baseline at immediately post-intervention
Title
Change on pain intensity.
Description
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).
Time Frame
Change from Baseline at immediately post-intervention
Secondary Outcome Measure Information:
Title
Change on cardiorespiratory capacity.
Description
Will be used the 6-minute walk test.
Time Frame
Change from Baseline at immediately post-intervention
Title
Change on functional mobility
Description
Will be used the Time up and go test.
Time Frame
Change from Baseline at immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
72220-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
29224694
Citation
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.
Results Reference
background
PubMed Identifier
28436583
Citation
Geneen 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.
Results Reference
background
PubMed Identifier
25694111
Citation
Kamper 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.
Results Reference
background
PubMed Identifier
17671236
Citation
Nelson 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.
Results Reference
background
PubMed Identifier
36119552
Citation
Ribeiro 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.
Results Reference
derived

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Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

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