Effect of Action Observation Training in Older Adults.

Aging Clinical Trial

— OAMT  

Official title:

Comparison of the Effect on Functionality of Multicomponent Training With and Without Action Observation in Older Adults.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05957133
• Other study ID #: USalamancaAO
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: July 2023
• Source: University of Salamanca
• Contact: Luis Polo Ferrero, MsC
• Phone: 6899919744
• Email: pfluis[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Exercise

Intervention

Procedure:
• Multicomponent exercise without action observation.
Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-five weeks
Secondary	Gait speed	It is considered a fast, safe and very reliable test, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.	thirty-five 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-five weeks
Secondary	Grip strength test	Accurate measurement of hand grip strength requires the use of a calibrated hand dynamometer (Jamar Plus) under well-defined (standardised) test conditions. Force values below 16 kg are considered positive and indicate weakness.	thirty-five weeks
Secondary	Chair stand test	It can be used as an indicator of lower limb muscle strength. It measures the time it takes a patient to stand up five times from a seated position without using the arms. Times greater than 15 seconds are considered positive and indicate weakness.	thirty-five weeks
Secondary	Step-Up Box Test	Consists of climbing for two minutes on a 35 cm box as many times as possible. it trains the strength of the lower brain but also the cardiovascular resistance is assessed.	thirty-five 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-five weeks
Secondary	Body fat percentage	is total fat mass divided by total body mass, multiplied by 100. This is another obesity indicator like BMI.	thirty-five weeks