Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05957133
Brief Summary:
Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. At the beginning and at the end of the programme, data were collected on participants' balance, fall risk and other parameters, using anthropometric tests (weight, % body fat and body mass index (BMI)), and physical performance tests (grip strength, the Short Physical Performance Battery, TUG and the stair step test). Study participants performed three 50-minute sessions per week for a total of 35 weeks. The components of balance, gait, cardiovascular resistance, stability, upper and lower limb strength, flexibility and breathing exercises were worked on. In the OC group, the physiotherapist performed the entire session together with the participants, while in the other group, the physiotherapist simply ordered the exercises.
Detailed Description:
Design: Randomised, controlled clinical trial with two parallel groups, in which adults over 65 years of age will be recruited. Study participants will be assigned to one of the two interventions. The study will have a duration of 35 weeks. There will be 2 evaluation visits, one initial, one final. During the intervention period there will be 3 weekly sessions of 50 minutes.
Scope: The study will be carried out in the Health Area of Salamanca, 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) Multicomponent Exercise Group (GEM); 2) Multicomponent Exercise and Action Observation Group (GOA). The GEM and GOA sessions follow the same design, according to the recommendations of the American College of Sports Medicine (ACSM), the only difference being that in the GOA the physiotherapist will perform all the exercises with the participants.
Study population: Adults over 65 years of age from the city of Salamanca will be included, distributed in 2 groups in a 1:1 ratio. Randomisation will be performed using the Epidat 4.2 programme. 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 (CS), hand grip test (HG) and Short Physical Performance Battery (SPPB)), gait speed (GS). stair step test; and body composition (% body fat, body weight, body mass index (BMI)).
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 established as the limit of statistical significance. The statistical programme to be used will be SPSS, v.26.0.
The study will be carried out with the authorisation of the Ethics Committee for Research with Medicines (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. Participants will be informed of the objectives of the project and of the risks and benefits of the tests and interventions to be performed. The study has been designed and subsequently evaluated 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 on human beings, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
Study:
NCT05957133
Study Brief:
Protocol Section:
NCT05957133