Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

Chronic Pain Clinical Trial

Official title:

Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719130
• Other study ID #: UNB11121
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: January 2021
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 25, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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,
• 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.

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasilia	Distrito Federal

Sponsors (4)

Lead Sponsor	Collaborator
University of Brasilia	Federal University of Minas Gerais, Federal University of Tocantins, Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change on cardiorespiratory capacity.	Will be used the 6-minute walk test.	Change from Baseline at immediately post-intervention
Secondary	Change on functional mobility	Will be used the Time up and go test.	Change from Baseline at immediately post-intervention