NCT04830319

Pilates Method in People With HAM/TSP

Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pedreira, Érika, M.D. · Individual
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p \<0.05 will be considered a statistically significant difference.

Conditions

• HAM/TSP
• HTLV-1 Secondary Myelopathy
• Balance
• Gait Balance
• Functional Mobility

Interventions

Type	Name	Description
OTHER	Pilates Method	includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.
OTHER	task-oriented training protocol	The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises.

Timeline

• Start date: 2018-02-20
• Primary completion: 2018-08-20
• Completion: 2020-03-15
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: Brazil