CClinicalTrials.gg
CompletedNCT04165434Updated Jun 16, 2020

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

An interventional study of Concurrent Training in Amputation of Lower Limb Above Knee and Sequelae, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 5 months after the study started (first participant enrolled May 2012, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the detailed description

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. The evaluation consisted of anamnesis (inclusion criteria), clinical and functional evaluation, cardiopulmonary exercise testing, isokinetic knee testing, static and dynamic posturography. The age of the group was 28.5 ± 7.1 years old, BMI 25 ± 4.8 kg.m-2, amputation time 22 ± 27.5 months, 83% were men and 57% with amputation on the left side, 11% used antidepressants and 11% antihypertensive medicine.

KEYWORDS: Transtibial amputation; Concurrent training; Rehabilitation, Comparative Study.

02

Conditions studied

  • Amputation of Lower Limb Above Knee
  • Sequelae

Keywords

  • Concurrent Training
  • Rehabilitation
03

In context

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Experimental

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

    Other: Concurrent Training

  • No intervention
    Control

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

Interventions

  • OtherConcurrent Training

    Strength training and interval aerobic training in the same training session

06

What researchers measure

Primary outcomes

  1. 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).

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

  2. 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).

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

  3. Abiliity Test- Climb Steps

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

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

  4. 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).

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

  5. 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.

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

  6. 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.

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

07

Study locations

1 site
  • Julia Maria D'Andrea Greve
    São Paulo, 04503-010, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04165434
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Sponsor
First posted
Nov 18, 2019
Start date
May 2012
Primary completion
Nov 2017
Completion
Feb 2020
Last update
Jun 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion