NCT04719130

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

August 15, 2023

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 12, 2021

Last Update Submit

August 12, 2023

Conditions

Keywords

Exercise TherapyMultimodal exercise

Outcome Measures

Primary Outcomes (3)

  • 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 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.

    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).

    Change from Baseline at immediately post-intervention

Secondary Outcomes (2)

  • Change on cardiorespiratory capacity.

    Change from Baseline at immediately post-intervention

  • Change on functional mobility

    Change from Baseline at immediately post-intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Will received multimodal circuit exercise group.

Other: Multimodal circuit exercise

Control Group

ACTIVE COMPARATOR

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

Other: Multidisciplinary lectures

Interventions

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,

Experimental Group

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.

Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Brasilia

Brasília, Federal District, 72220-900, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 29224694BACKGROUND
  • 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.

    PMID: 28436583BACKGROUND
  • 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.

    PMID: 25694111BACKGROUND
  • 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.

    PMID: 17671236BACKGROUND
  • 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.

MeSH Terms

Conditions

Musculoskeletal PainChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Another researcher collaborator (blinded) will be carried out the outcomes investigated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized parallel study (two arms) with blinded outcome assessments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 22, 2021

Study Start

August 30, 2021

Primary Completion

February 1, 2022

Study Completion

April 25, 2022

Last Updated

August 15, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations