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Effectiveness of Power Training in Older Women With Pre-sarcopenia (POSARC)

Primary Purpose

Pre-sarcopenia, Old Age; Debility

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Power training in women older than 65 years with pre-sarcopenia
Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-sarcopenia focused on measuring exercise, elderly, resistance training, sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Salamanca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

power exercise group

multimodal exercise group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

SARC-F questionnaire
A simple questionnaire to rapidly diagnose sarcopenia with 5 questions for the initial detection of risk of sarcopenia (5 components: Strength, assistance in walking, rise from a chair, climb stairs, and falls). A score equal to or greater than 4 points better predicts the need for a more comprehensive evaluation.
Evaluation of changes in contraction velocity (m/s)
Velocity (m/s) of concentric contraction execution of a full extension of the lower limb will be evaluated to assess the changes in the force-velocity profile after performing the different interventions. It will be measured using the ADR linear encoder device and the mean value of five repetitions will be obtained.
Body Mass Index (BMI)
It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
Short Physical Performance Battery (SPPB)
Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
Gait speed
It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
Timed Up and Go (TUG)
A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
Mini Nutritional Assessment (MNA®) screening tool.
: A dietary assessment will be carried out, through a dietary intake diary (3-day food record) and a consumption frequency questionnaire; and a nutritional assessment, aimed at detecting malnutrition

Full Information

First Posted
May 8, 2023
Last Updated
June 26, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05870046
Brief Title
Effectiveness of Power Training in Older Women With Pre-sarcopenia
Acronym
POSARC
Official Title
Effectiveness of Power Training Compared With Non-specific Exercises on Functionality and Body Composition in Women Older Than 65 Years With Pre-sarcopenia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Design: Randomized, controlled clinical trial with three parallel groups, in which women over 65 years of age will be recruited. Study participants will be assigned to one of the three interventions. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, a final one at 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes. Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council. Interventions: 1) Multimodal Exercise Group (GEM); 2) Muscle Power Exercise Group (GEP); 3) No Exercise Control Group (CG). The GEM and GEP sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GEP, strength exercises will be performed and the speed will be progressively increased until the exercises are performed at the maximum speed that each participant can do. Study population: 104 subjects over 65 years of age from the city of Salamanca will be included, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012. The main study variables are: 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)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed. Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0. The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-sarcopenia, Old Age; Debility
Keywords
exercise, elderly, resistance training, sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Longitudinal prospective, controlled, single-blind study
Masking
ParticipantOutcomes Assessor
Masking Description
Single blind masking with blinded assessor.
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
power exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
multimodal exercise group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Power training in women older than 65 years with pre-sarcopenia
Intervention Description
resistance training based on muscle power training, perform the exercises at high speed.
Intervention Type
Procedure
Intervention Name(s)
Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia
Intervention Description
different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.
Primary Outcome Measure Information:
Title
Grip strength test
Description
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.
Time Frame
thirty weeks
Title
Chair stand test
Description
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
Time Frame
thirty weeks
Secondary Outcome Measure Information:
Title
SARC-F questionnaire
Description
A simple questionnaire to rapidly diagnose sarcopenia with 5 questions for the initial detection of risk of sarcopenia (5 components: Strength, assistance in walking, rise from a chair, climb stairs, and falls). A score equal to or greater than 4 points better predicts the need for a more comprehensive evaluation.
Time Frame
thirty weeks
Title
Evaluation of changes in contraction velocity (m/s)
Description
Velocity (m/s) of concentric contraction execution of a full extension of the lower limb will be evaluated to assess the changes in the force-velocity profile after performing the different interventions. It will be measured using the ADR linear encoder device and the mean value of five repetitions will be obtained.
Time Frame
thirty weeks
Title
Body Mass Index (BMI)
Description
It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
Time Frame
thirty weeks
Title
Short Physical Performance Battery (SPPB)
Description
Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
Time Frame
thirty weeks
Title
Gait speed
Description
It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
Time Frame
thirty weeks
Title
Timed Up and Go (TUG)
Description
A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
Time Frame
thirty weeks
Title
Mini Nutritional Assessment (MNA®) screening tool.
Description
: A dietary assessment will be carried out, through a dietary intake diary (3-day food record) and a consumption frequency questionnaire; and a nutritional assessment, aimed at detecting malnutrition
Time Frame
thirty weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women older than 65 years with a pre-sarcopenia state are included.
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women older than 65 years. pre-sarcopenia state (chair stand test > 15s or Hand Grip Strength < 16Kg). Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Méndez Sánchez, PhD
Phone
+34 923294500
Ext
3201
Email
ro_mendez@usal.es
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Power Training in Older Women With Pre-sarcopenia

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