Effect of Action Observation Training in Older Adults.

NCT ID: NCT05957133

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-03-30

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.

Conditions

Aging; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multicomponent exercise group without action observation (MTG)

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.

Group Type: ACTIVE_COMPARATOR

Multicomponent exercise without action observation.

Intervention Type: PROCEDURE

Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.

Multicomponent exercise group associated to action observation (AOG)

It is the same intervention as the other group with the addition of the observation of actions thanks to the fact that the physiotherapist carries out the exercises with them at all times.

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 exercises will be the same as in the other group.

Group Type: EXPERIMENTAL

Multicomponent exercise associated with action observation

Intervention Type: PROCEDURE

Different exercise modalities are integrated: aerobic, mobility, strength, balance and coordination exercises carried out at all times by the physiotherapist and observed by the participants.

Interventions

Multicomponent exercise without action observation.

Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.

Intervention Type: PROCEDURE

Multicomponent exercise associated with action observation

Different exercise modalities are integrated: aerobic, mobility, strength, balance and coordination exercises carried out at all times by the physiotherapist and observed by the participants.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• adults over 65 years of age.

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Luis Polo Ferrero

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Luis Polo Ferrero, MsC

Role: CONTACT

pfluis@usal.es

6899919744

Roberto Méndez Sánchez, PhD

Role: CONTACT

ro_mendez@usal.es

923294500 ext. 3201

Other Identifiers

USalamancaAO

Identifier Type: -

Identifier Source: org_study_id