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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04165434

Enrollment

Registered

2019-11-18

Start date

2012-05-31

Completion date

2020-02-29

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation of Lower Limb Above Knee, Sequelae

Keywords

Concurrent Training, Rehabilitation

Brief summary

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.

Interventions

OTHERConcurrent Training

Strength training and interval aerobic training in the same training session

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Functional assessment- Sit to Stand	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	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).
Functional Mobility - Time-up and Go Test	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	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).
Abiliity Test- Climb Steps	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	Time to climb 15 steps (height 15 centimeters / depth 30 centimeters), as quickly as possible; measured in time - seconds (sec).
Muscular strength- Isokinetic Dynamometry	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	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).
Exhaled gas analyze - Ergospirometry	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	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.
Dynamic and static balance-Balance platform	This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026