Muscle Strength Training in Lower Limb Amputee Patients
ConditionLower Limb Amputation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Gran Rosario
About this trial
This study is a clinical trial that evaluates the best treatment option using a strength training protocol and an endurance training protocol in patients with lower limb amputations who use prostheses. The protocol consists of 6 weeks of strength training and 6 weeks of endurance training, with a 1-month washout period between the two.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with unilateral lower limb amputation
Transtibial and/or transfemoral amputation
Prosthetized
Aged 18 to 75 years
Disqualifiers
That they are unable to complete the initial assessment
That they undergo further secondary training
Trial design
Design model
Crossover
Treatments tested in this trial
Muscle strengh training
Other interventionStrength training lasts six weeks, during which submaximal strength percentages ranging from 75% to 90% are worked on. It is performed three times a week and follows a protocol consisting of progressive exercises for the large functional muscle groups relevant to the population being trained.
Resistence training
Other interventionResistance training will be carried out for 6 weeks, 3 times a week, with exercises prescribed by a protocol with training characteristics defined by bibliography found in the ACSM.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Muscle strength trainingExperimental treatment 1 intervention
Group B: Endurance trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Funcionality
It is assessed using the TUG test, which requires patients to get up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. Patients will receive the following instructions: "Get up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down."
Time frame
day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.2
Changes in quality of life
It is assessed using a self-administered questionnaire called WHOQOL-BREF, which provides a profile of the person's perceived quality of life.
Time frame
day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.Secondary outcomes
1
Changes in Maximum isometric muscle strength
It is evaluated using a dynamometer, in which three measurements are taken for each designated movement and the average of the maximum force and peak force is calculated.
Time frame
day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.2
Changes on Movility
It is assessed using the AMP functional rating scale (amputee mobility predictor).
Time frame
day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.3
Change in Global percepcion of change
It is an assessment carried out using the Groc scale, which evaluates changes in perception.
Time frame
assessments were performed at the end each protocol. day 18 and day 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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