Amputation of Lower Limb Above KneeNCT04165434
Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation
A study testing Concurrent Training in people with Amputation of Lower Limb Above Knee and Sequelae, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Amputation of Lower Limb Above Knee, Sequelae
- What is being tested?
- Concurrent Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Eight-week Concurrent Training on Functional Capacity, Force, Balance in Patients With Unilateral Transtibial Amputation
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.
- Conditions
- Amputation of Lower Limb Above Knee, Sequelae
- Being tested
- Concurrent Training
- Keywords
- Concurrent Training, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent TrainingOther
Strength training and interval aerobic training in the same training session
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Untrained unilateral transtibial amputees who underwent the assessment and recommended training. Receives: Other: Concurrent Training |
| Control | No intervention | Untrained unilateral transtibial amputees who after the evaluation were not included for the recommended training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study startMay 2012
- Primary completionNov 2017
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Lower Limb Above KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165434
- Sponsor's protocol ID
- Amputados
- Status last verified
- Feb 2018
- First submitted
- 11 Oct 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eight-week Concurrent Training on Functional Capacity, Force, Balance in Patients With Unilateral Transtibial Amputation
- ClinicalTrials.gov ID
- NCT04165434
- Acronym / sponsor ID
- Amputados
- Conditions
- Amputation of Lower Limb Above Knee, Sequelae
- Keywords
- Concurrent Training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Concurrent TrainingUntrained unilateral transtibial amputees who underwent the assessment and recommended training. |
| Control | No intervention | –Untrained unilateral transtibial amputees who after the evaluation were not included for the recommended training. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent TrainingStrength training and interval aerobic training in the same training session | Other | Experimental |
Primary outcome
Functional assessment- Sit to Stand
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Training in people with Amputation of Lower Limb Above Knee and Sequelae, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessment- Sit to Stand (time frame: This measure will be performing before and after the innervation (8 weeks of concurrent training 3 times a week.).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.