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Not yet recruiting NCT07261852

Muscle Strength Training in Lower Limb Amputee Patients

No phase Interventional Lower Limb Amputation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle strengh training, Resistence training.
Who it may be relevant to
Registry conditions: Lower Limb Amputation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Muscle Strength Training in Lower Limb Amputee Patients

Overview

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.

Detailed description

The assessments in this study focus primarily on strength, using a dynamometer and the 5 RM, functionality, using the AMP scale, mobility, using the TugTest, quality of life, using the WHOQOL-BREF, and perception of change, using the GROC.

Interventions

  • Other Muscle strengh training
    Strength 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.
  • Other Resistence training
    Resistance 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.

Primary outcome measures

  • Changes in Funcionality [Time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.]
  • Changes in quality of life [Time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.]
Secondary outcome measures (3)
  • Changes in Maximum isometric muscle strength [Time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.]
  • Changes on Movility [Time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.]
  • Change in Global percepcion of change [Time frame: assessments were performed at the end each protocol. day 18 and day 24]

Eligibility criteria

Inclusion criteria

  • Patients with unilateral lower limb amputation
  • Transtibial and/or transfemoral amputation
  • Prosthetized
  • Aged 18 to 75 years
  • Who sign the informed consent form

Exclusion criteria

  • That they are unable to complete the initial assessment
  • That they undergo further secondary training

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07261852 · 619/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗