Muscle Strength Training in Lower Limb Amputee Patients

Effects of Muscle Strength Training in Lower Limb Amputee Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Other: Muscle strengh training; Other: Resistence training

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela B Dell´Elce; Phone Number: +54 3462344478; Email: gdellelce@ugr.edu.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle strength 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: 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.
Active Comparator: Endurance 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
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.	day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Changes on Movility	It is assessed using the AMP functional rating scale (amputee mobility predictor).	day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Change in Global percepcion of change	It is an assessment carried out using the Groc scale, which evaluates changes in perception.	assessments were performed at the end each protocol. day 18 and day 24

Collaborators and Investigators

• Sponsor: University of Gran Rosario
• Investigators: Study Director: Mauro S Barone, Ugr

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; muscle strength; amputees; endurance training; funcionality; movility
• Other Study ID Numbers: 619/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If necessary or required, informed consent and data analysis will be shared.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No