Clinical trial NCT04719130: 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
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Pain
Keywords: Exercise Therapy
Multimodal exercise
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
name: Federal University of Tocantins
name: Universidade Federal de Goias
First posted: 2021-01-22
Enrollment: 113
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized parallel study (two arms) with blinded outcome assessments.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on pain intensity.
timeFrame: Change from Baseline at immediately post-intervention
measure: Change on disability.
timeFrame: Change from Baseline at immediately post-intervention
measure: Change on pain intensity.
timeFrame: Change from Baseline at immediately post-intervention
Secondary outcomes:
measure: Change on cardiorespiratory capacity.
timeFrame: Change from Baseline at immediately post-intervention
measure: Change on functional mobility
timeFrame: Change from Baseline at immediately post-intervention
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
References:
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.
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.
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.
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.
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.