Effectiveness of Power Training in Older Women With Pre-sarcopenia

Old Age; Debility Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05870046
• Other study ID #: USalamancaPowerSarcopenia
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Old Age; Debility
• Sarcopenia

Intervention

Procedure:
• Power training in women older than 65 years with pre-sarcopenia
resistance training based on muscle power training, perform the exercises at high speed.
• Multimodal and nonspecific exercises in women older than 65 years with pre-sarcopenia
different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.

Locations

Country	Name	City	State
Spain	University of Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	thirty weeks
Secondary	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.	thirty weeks
Secondary	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).	thirty weeks
Secondary	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.	thirty weeks
Secondary	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.	thirty weeks
Secondary	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.	thirty weeks
Secondary	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	thirty weeks