Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation

NCT04165434 | Completed

• 1 other identifier: Amputados
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength, power and cardiorespiratory fitness on muscle condition, balance, load distribution in the lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA). MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected. Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained unilateral transtibial (UUT) amputees who after the evaluation were not included for the recommended training. All patients were evaluated at the baseline time of randomization and eight weeks after

Conditions

Amputation of Lower Limb Above Knee; Sequelae

Keywords

Concurrent Training; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Functional assessment- Sit to Stand

  Dynamic functional capacity assessment: patient sit to stand from a standard chair (40 centimeters high, 45 centimeters wide and backrest 90 degrees). Have to do the task five times as fast as possible time; measured in time - seconds (sec).

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

• Functional Mobility - Time-up and Go Test

  Time-up and Go Test (TUGT) - patient sit in a standard chair (40 centimeters high, 45 centimeters wide and backrest 90 degrees), trunk resting on backrest, after a verbal command has to stand up, walk for three meters (m) turn, return and sit in the chair as fast as possible; measured in time - seconds (sec).

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

• Abiliity Test- Climb Steps

  Time to climb 15 steps (height 15 centimeters / depth 30 centimeters), as quickly as possible; measured in time - seconds (sec).

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

• Muscular strength- Isokinetic Dynamometry

  Evaluation of muscular strength improvement - Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used were maximum peak torque corrected for body weight (%), and total work (J).

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

• Exhaled gas analyze - Ergospirometry

  An exercise bike exercise test (Biocycle 2600 Electromagnetic Moviment, Brazil) was performed using the modified Astrand protocol which recommends a speed of 60 revolutions per minute (rpm) with progressive load increase (w). Two minutes (min) and the load was increased by 25 by 25 watts (w) in a stepwise fashion until maximum effort was achieved. Exhaled gas analysis was performed using the computerized metabolic gas analyzer (CPX / Ultima, MedGraphics®, St. Paul, Minnesota, USA). The maximum oxygen uptake (VO2max in ml / kg / min) was mainly evaluated.

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

• Dynamic and static balance-Balance platform

  Static and dynamic balance was evaluated by the Balance Master System version 8.1 (NeuroCom International, Inc. Clackamas, OR). The system consists of a dual force platform coupled to a microcomputer. Platform force sensors measure ground reaction force (° / s) while performing tasks such as sitting and rising from a chair by measuring the force distribution between the lower limbs in percent (%). The variables will be the mean weight transfer index (%), mean movement time (s) and mean impact index.

  This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).

Study Arms (2)

Experimental

EXPERIMENTAL

Untrained unilateral transtibial amputees who underwent the assessment and recommended training.

Other: Concurrent Training

Control

NO INTERVENTION

Untrained unilateral transtibial amputees who after the evaluation were not included for the recommended training.

Interventions

Concurrent Training OTHER

Strength training and interval aerobic training in the same training session

Experimental

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Transtibial amputation (any etiology)
• Age between 18 - 50 years
• Absence of any musculoskeletal and/or inflammatory diseases; central and/or peripheral neuropathy; psychiatry alteration
• Discharge of the rehabilitation program and the use of a prosthesis for three or more months and more.

You may not qualify if:

• Pain or inability to complete any of the tests
• High blood pressure (over 130 x 90 mmHg) before strength evaluation
• Loss of three consecutive training sessions and no return for the reevaluation session

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Julia Maria D'Andrea Greve

São Paulo, 04503-010, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 18, 2019
• Study Start: May 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2018-02

Locations

BR (1)