Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

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

Detailed Description
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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.

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

Conditions
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Musculoskeletal Pain, Chronic Pain

Intervention / Treatment
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* Other: Multimodal circuit exercise
* Other: Multidisciplinary lectures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized parallel study (two arms) with blinded outcome assessments.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Will received multimodal circuit exercise group. | Other: Multimodal circuit exercise<br>* 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,<br>|
| Active Comparator: Control Group<br>Will received multidisciplinary lectures on pain and usual care provided by the Basic Health Units. | Other: Multidisciplinary lectures<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on cardiorespiratory capacity. | Will be used the 6-minute walk test. | Change from Baseline at immediately post-intervention | 
| Change on functional mobility | Will be used the Time up and go test. | Change from Baseline at immediately post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Multimodal exercise