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Completed

NCT Number: NCT04719130

Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

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

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Key information

Conditions

Musculoskeletal Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Brasilia

Brasília, Federal District, 72220-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal circuit exercise

Other

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

Other

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 outcomes

  1. Change on pain intensity.

    Time frame: Change from Baseline at immediately post-intervention

    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".

  2. Change on disability.

    Time frame: Change from Baseline at immediately post-intervention

    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.

  3. Change on pain intensity.

    Time frame: Change from Baseline at immediately post-intervention

    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 outcomes

  1. Change on cardiorespiratory capacity.

    Time frame: Change from Baseline at immediately post-intervention

    Will be used the 6-minute walk test.

  2. Change on functional mobility

    Time frame: Change from Baseline at immediately post-intervention

    Will be used the Time up and go test.

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Collaborators

  • Federal University of Minas Gerais
  • Federal University of Tocantins
  • Universidade Federal de Goias

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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