Clinical trial NCT04165434: Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation
Official title: Effect of Eight-week Concurrent Training on Functional Capacity, Force, Balance in Patients With Unilateral Transtibial Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation of Lower Limb Above Knee
Sequelae
Keywords: Concurrent Training
Rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional assessment- Sit to Stand
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
measure: Functional Mobility - Time-up and Go Test
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
measure: Abiliity Test- Climb Steps
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
measure: Muscular strength- Isokinetic Dynamometry
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
measure: Exhaled gas analyze - Ergospirometry
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
measure: Dynamic and static balance-Balance platform
timeFrame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Julia Maria D'Andrea Greve
Study officials:
References: