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

NCT ID: NCT04165434

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amputation of Lower Limb Above Knee Sequelae

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

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

Group Type EXPERIMENTAL

Concurrent Training

Intervention Type OTHER

Strength training and interval aerobic training in the same training session

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Concurrent Training

Strength training and interval aerobic training in the same training session

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Julia Maria D'Andrea Greve

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Amputados

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.