NCT05870046

Brief Summary

This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of resistance training based on power training, multimodal exercise with non-specific exercises and a control group on functionality and body composition in women over 65 years of age with pre-sarcopenia. The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

May 8, 2023

Last Update Submit

March 18, 2025

Conditions

Keywords

exerciseelderlyresistance trainingsarcopenia

Outcome Measures

Primary Outcomes (2)

  • Grip strength test

    Accurate measurement of hand grip strength requires the use of a hand dynamometer (Jamar Plus) calibrated under well-defined (standardized) test conditions. Force values less than 16 Kg are considered positive.

    thirty weeks

  • Chair stand test

    It can be used as an indicator of the strength of the lower limb muscles. It measures the amount of time a patient needs to get up five times from a sitting position without using their arms. It will help us to affirm that the person has a probable sarcopenia. Times greater than 15 seconds are considered positive

    thirty weeks

Secondary Outcomes (7)

  • SARC-F questionnaire

    thirty weeks

  • Evaluation of changes in contraction velocity (m/s)

    thirty weeks

  • Body Mass Index (BMI)

    thirty weeks

  • Short Physical Performance Battery (SPPB)

    thirty weeks

  • Gait speed

    thirty weeks

  • +2 more secondary outcomes

Study Arms (3)

power exercise group

EXPERIMENTAL

The main part of the muscle power exercise program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, dead weight, front and sagittal plan stride, and heel raises. It will have different phases: * 1st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month. * 2nd phase: Resistance training: During the following two months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course. * 3rd phase: Muscle power training: During the last five months. A correct progression of the load and a progressive increase in the speed of execution of the different exercises will be carried out, gradually increasing the levels of difficulty and intensity.

Procedure: Power training in women older than 65 years with pre-sarcopenia

multimodal exercise group

ACTIVE COMPARATOR

The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the different models is as follows: * E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work. * E. Strength: Increase sets, repetitions and decrease rest time. * Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc. * Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making.

Procedure: Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia

Control group

NO INTERVENTION

Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program based on muscle power, nor will they perform systematic, programmed and supervised physical exercise in any other program.

Interventions

resistance training based on muscle power training, perform the exercises at high speed.

power exercise group

different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.

multimodal exercise group

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women older than 65 years with a pre-sarcopenia state are included.
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women older than 65 years.
  • pre-sarcopenia state (chair stand test \> 15s or Hand Grip Strength \< 16Kg).

You may not qualify if:

  • Tumors
  • Pacemakers
  • Fibrillations
  • Cardiac pathology or uncontrolled hypertension
  • History of severe trauma/recent cervical surgery
  • Uncontrolled systemic and inflammatory pathologies
  • Congenital collagen compromise
  • Presence of difficulties in performing the Initial Evaluation tests
  • Language barriers
  • Pending litigation or legal claim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

Location

Related Publications (2)

  • Polo-Ferrero L, Recio-Rodriguez JI, Gonzalez-Manzano S, Martin-Vallejo J, Barbero-Iglesias FJ, Montero-Errasquin B, Cruz-Jentoft AJ, Mendez-Sanchez R. Nutritional intake as a determinant of high-speed resistance and multicomponent training efficacy on strength in older women at risk of sarcopenia. A randomized clinical trial. Clin Nutr. 2025 Apr;47:103-111. doi: 10.1016/j.clnu.2025.02.015. Epub 2025 Feb 19.

  • Polo-Ferrero L, Saez-Gutierrez S, Davila-Marcos A, Barbero-Iglesias FJ, Sanchez-Sanchez MC, Puente-Gonzalez AS, Mendez-Sanchez R. Effect of power training on function and body composition in older women with probable sarcopenia. A study protocol for a randomized controlled trial. PLoS One. 2025 Jan 6;20(1):e0313072. doi: 10.1371/journal.pone.0313072. eCollection 2025.

MeSH Terms

Conditions

FrailtyMotor ActivitySarcopenia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Single blind masking with blinded assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Longitudinal prospective, controlled, single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 23, 2023

Study Start

February 15, 2022

Primary Completion

December 31, 2023

Study Completion

February 28, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations