Clinical trial NCT05870046: Effectiveness of Power Training in Older Women With Pre-sarcopenia
Official title: Effectiveness of Power Training Compared With Non-specific Exercises on Functionality and Body Composition in Women Older Than 65 Years With Probable Sarcopenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-sarcopenia
Old Age; Debility
Keywords: exercise
elderly
resistance training
sarcopenia
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal prospective, controlled, single-blind study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Grip strength test
timeFrame: thirty weeks
measure: Chair stand test
timeFrame: thirty weeks
Secondary outcomes:
measure: SARC-F questionnaire
timeFrame: thirty weeks
measure: Evaluation of changes in contraction velocity (m/s)
timeFrame: thirty weeks
measure: Body Mass Index (BMI)
timeFrame: thirty weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: thirty weeks
measure: Gait speed
timeFrame: thirty weeks
measure: Timed Up and Go (TUG)
timeFrame: thirty weeks
measure: food frequency questionnaire (FFQ)
timeFrame: thirty weeks
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
References: