Muscle Strength Training in Lower Limb Amputee Patients

NCT07261852 | Not Yet Recruiting

• 1 other identifier: 619/2024
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Limb Amputation

Keywords

amputees; quality of life; funcionality; muscle strength; movility; endurance training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in Maximum isometric muscle strength

  day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.

• Changes on Movility

  day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.

• Change in Global percepcion of change

  assessments were performed at the end each protocol. day 18 and day 24

Study Arms (2)

Muscle strength training

EXPERIMENTAL

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

Endurance training

ACTIVE COMPARATOR

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

Interventions

Resistence training OTHER

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.

Endurance training

Muscle strengh training OTHER

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.

Muscle strength training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Officials

• Mauro S Barone

  Ugr

  STUDY DIRECTOR

Central Study Contacts

Gabriela B Dell´Elce

CONTACT

+54 3462344478; gdellelce@ugr.edu.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 3, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF