Pilates Method in People With HAM/TSP

NCT04830319 | Completed

• 1 other identifier: HTLVIDA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Balance

  Berg's Balance Scale (BBS)

  15 minutes

• Functional Mobility

  Timed up and Go (TUG)

  3 minutes

• Gait Balance

  Dynamic Gait Index (DGI)

  10 minutes

• Balance

  Balance Evaluation Systems Test of dynamic balance (mini-BESTest)

  20 minutes

Study Arms (2)

Test-control group (TCG)

EXPERIMENTAL

The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which 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.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. The TCG group will then conduct 20 task-oriented training sessions

Other: Pilates Method; Other: task-oriented training protocol

Control-test group (CTG)

ACTIVE COMPARATOR

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.

Other: Pilates Method; Other: task-oriented training protocol

Interventions

Pilates Method OTHER

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.

Control-test group (CTG); Test-control group (TCG)

task-oriented training protocol OTHER

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.

Control-test group (CTG); Test-control group (TCG)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years.

You may not qualify if:

• individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.

Sponsors & Collaborators

• Pedreira, Érika, M.D.: lead

Study Sites (1)

Universidade Católica do Salvador

Salvador, Estado de Bahia, 40000-00, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: April 5, 2021
• Study Start: February 20, 2018
• Primary Completion: August 20, 2018
• Study Completion: March 15, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)