NCT06895122

Brief Summary

This study is a randomized, parallel-group, double-blind clinical trial. The primary aim is to assess the effectiveness of power-based resistance training, multimodal exercise incorporating non-specific movements, and a control group in improving functionality and body composition in women over 65 years old with pre-sarcopenia. The intervention will take place over 30 weeks, with three training sessions per week in both experimental groups. Assessments will be conducted at two time points: before and after the intervention. Evaluated parameters will include functionality (Timed Up \& Go test (TUG), chair stand test, handgrip strength, and Short Physical Performance Battery (SPPB)) and body composition (body fat percentage, skeletal muscle index (SMI), appendicular skeletal muscle mass (ASM), waist circumference, waist-to-hip ratio, body weight, and body mass index (BMI)).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 18, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

Resistance trainingExerciseOlder adultsMulticomponent training

Outcome Measures

Primary Outcomes (1)

  • Skeletal Muscle Index (SMI)

    The SMI assesses muscle mass relative to body size, calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m²). Sarcopenia is diagnosed in women when SMI is \<5.5 kg/m²

    30 weeks

Secondary Outcomes (7)

  • Body Fat Percentage (BF%)

    30 weeks

  • Grip strength test

    30 weeks

  • Chair stand test

    30 weeks

  • Body Mass Index (BMI)

    30 weeks

  • Short Physical Performance Battery (SPPB)

    30 weeks

  • +2 more secondary outcomes

Study Arms (3)

High Speed Resistance Training

EXPERIMENTAL

The core component of the H-RT program will include a variety of exercises targeting both the upper and lower limbs. These exercises consist of wall push-ups, arm raises, elbow flexion and extension, weighted pronosupination, hand presses, knee and hip hinge squats, deadlifts, frontal and sagittal plane lunges, and heel raises. The program will be structured into three progressive phases: Phase 1 - Adaptation: During the first month, participants will focus on learning the correct technique for all upper and lower limb exercises to ensure proper execution. Phase 2 - Strength Training: Over the next two months, resistance exercises will be performed at both slow and controlled speeds, reinforcing movement patterns established in the initial phase. Phase 3 - High-Speed Resistance Training: In the final five months, progressive overload will be applied, with a gradual increase in execution speed and exercise intensity to enhance muscle power and improve overall function

Procedure: High resistance training

Multicomponent training

ACTIVE COMPARATOR

The core of the multicomponent exercise program incorporates various exercise modalities, including aerobic training, mobility, strength, balance, and coordination exercises. Additionally, playful activities and cognitive tasks are integrated to enhance the program's overall effects. These include games involving colors, numbers, letters, laterality (right-left distinction), memory exercises, and more. The progression for each modality follows a structured approach: Aerobic Training: Begins with continuous exercise, transitions to interval training, and progressively reduces rest periods. Strength Training: Gradually increases the number of sets and repetitions while decreasing rest time. Balance Training: Starts with static exercises and progresses to more challenging tasks, incorporating blindfolds, perturbations, and dynamic balance drills. Coordination and Cognitive Tasks: Exercises become progressively more complex, requiring faster decision-making and more intricate movements.

Procedure: Multicomponent Training

Control Group

NO INTERVENTION

Participants assigned to this group will maintain their usual dietary habits and physical activity levels without making any lifestyle modifications throughout the study. They will not engage in the muscle power-based strength training program or participate in any other structured, supervised, or systematic exercise program.

Interventions

Participants will perform the exercises at high speed, emphasizing explosive movements to maximize muscle power development.

Also known as: Power training
High Speed Resistance Training

Various exercise modalities are integrated, including aerobic training, mobility, strength, balance, and coordination exercises.

Multicomponent training

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as women and meet the biological criteria of the study (i.e., assigned female at birth) are eligible to participate
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women older than 65 years.
  • Diagnosis of sarcopenic obesity (SMI \< 5.5 kg/m2, BMI \> 30 kg/m2)

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

MeSH Terms

Conditions

ObesityOverweightSarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalBehavior

Study Officials

  • Roberto Méndez Sánchez, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinding was performed on the study hypothesis and on the participants assigned to each group. Both the evaluating researchers and the statistical researcher were blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Longitudinal.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 26, 2025

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations