Benefits of tai chi training vs strength training combined with the mental stimulation of an ICOPE program on physical and mental functional capacity in older adults

ISRCTN ISRCTN55261971
DOI https://doi.org/10.1186/ISRCTN55261971
ClinicalTrials.gov number Nil Known
Secondary identifying numbers Nil Known
Submission date
15/05/2025
Registration date
03/06/2025
Last edited
02/06/2025
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
As people get older, staying healthy and independent becomes more important. The World Health Organization has a plan called ICOPE (Integrated Care for Older People) to help older adults stay active and live independently for as long as possible. This plan focuses on five key areas: thinking and memory, movement, nutrition, senses (like vision and hearing), and emotional health.
This study is looking at whether two types of exercise (Tai Chi and strength training) combined with mental exercises can help improve health in older adults. Researchers want to see how these activities affect things like body health, memory, mood, and quality of life.

Who can participate?
Adults aged 60 to 74 years who are generally healthy, with no serious physical or memory problems, and who haven’t taken anti-inflammatory or antioxidant supplements in the past 3 months.

What does the study involve?
Participants will be randomly placed into one of three groups:
1. Tai Chi with mental exercises
2. Strength training with mental exercises
3. A control group that doesn’t do either program
Before starting, and again at 6 and 12 months, participants will have health checks including blood tests, body measurements, heart tests, and assessments of memory, mood, and quality of life.
Those in the exercise groups will:
1. Do 60 minutes of physical activity, 4 days a week
2. Attend a two-hour mental stimulation session once a week
All participants will receive a smart bracelet to track their physical activity and sleep.

What are the possible benefits and risks of participating?
Participants in the exercise groups may improve their strength, memory, mood, sleep, and overall well-being.
There are no major risks, as all exercise sessions are supervised. Health checks will be done before each session, and any discomfort will be addressed by medical staff.

Where is the study run from?
The study is being conducted at the Gerontology Research Unit, Faculty of Higher Studies Zaragoza, National Autonomous University of Mexico (UNAM), in Mexico City.

When is the study starting and how long is it expected to run for?
February 2024 to December 2026.

Who is funding the study?
The study is funded by the National Autonomous University of Mexico (UNAM), through its General Management of Academic Personnel Affairs (DGAPA), under the PAPIIT Project IN307424.

Who is the main contact?
Dr Víctor Manuel Mendoza-Núñez, mendovic@unam.mx

Contact information

Dr Víctor Manuel Mendoza-Núñez
Public, Scientific, Principal Investigator

Batalla 5 de Mayo s/n esquina Fuerte de Loreto, Colonia Ejército de Oriente, Iztapalapa
Ciudad de México
09230
Mexico

ORCiD logoORCID ID 0000-0002-9137-3405
Phone +52 55 5623-0721
Email mendovic@unam.mx

Study information

Study designQuasi-experimental interventional non randomized study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format please use contact details to request a participant information sheet
Scientific titleEffect of tai chi training vs strength training combines with mental stimulation on physical and cognitive functional capacity in older adults within the framework of ICOPE
Study objectivesConsidering the scientific evidence on the effect of physical exercise combined with mental stimulation, we infer that the group participating in Tai Chi training combined with cognitive stimulation will show a significantly greater effect on clinical, anthropometric, biochemical, body composition, affective, well-being and quality of life parameters linked to physical and cognitive functional capacity than the group that performs Strength Exercise combined with the mental stimulation program within the framework of ICOPE.
Ethics approval(s)

Approved 29/08/2023, Research Ethics Committee of the FES Zaragoza, UNAM (Batalla 5 de Mayo s/n esquina Fuerte de Loreto, Colonia Ejército de Oriente, Iztapalapa, Mexico City, 09230, Mexico; +52 55 5623 0724; etica.enlace@zaragoza.unam.mx), ref: FESZ/CEl/1/1/8/21/23

Health condition(s) or problem(s) studiedPhysical and mental functional capacity in older adults
InterventionAll participants provide written informed consent before being included in the study. Groups will be randomly assigned using the Oxford Minimization and Randomization (OxMaR) software.

Group 1: Tai Chi combined with mental stimulation: taught over 8 weeks, Tai Chi 8-form and later 24-form training. It will be taught 4 days a week in 60-minute sessions in person. In addition, the class will be filmed so that people who cannot attend the in-person session can do the exercise at home.

Group 2: Strength training combined with mental stimulation: Multimodal exercise, including progressive strength training and other exercise components (balance, flexibility, and aerobic training), as recommended in the ICOPE guidelines. These sessions will be taught four days a week in 60-minute in-person sessions. In addition, the class will be filmed so that people who cannot attend the in-person session can do the exercise at home.
Physical training sessions design:
1. Warming: 5 minutes of joint lubrication and 5 minutes of activation exercise to increase heart rate (5 minutes).
2. Main exercise: This exercise will work on coordination, strength, and endurance, targeting the arms, legs, back, and other parts of the body (40 minutes).
3. Cool-down: Stretching and breathing exercises to improve flexibility and bring the body into a relaxed state (10 minutes).

Group 3: Older adults who are unable to participate in the physical exercise and mental stimulation program but who agree to participate in baseline, 6-month, and 12-month measurements of the study variables.

Mental stimulation program:
The program developed at the Gerontology Research Unit of the FES Zaragoza, UNAM, will be implemented. The program consists of 24 one-hour sessions once a week and includes activities to prevent and reverse mild cognitive impairment, taking into account the participants' sociocultural context. These activities include tasks to strengthen attention, executive functions, sensory stimulation, and elements of reminiscence and counselling therapy.

Each session follows the same format:
Step 1. Start: review of homework assigned in the previous session
Step 2. Main activity: group or individual exercise(s) to stimulate cognitive functions (analysis of a story, biography of a famous person, learning a song, analysis of a painting, film, and math exercises).
Step 3. Closing of the session: analysis of the activity carried out (participants' experience, guided by the workshop coordinator), assignment of homework to be completed throughout the week at home.
Intervention typeMixed
Primary outcome measure1. Cognitive functions measured using the Neuropsychological Assessment Battery: (i) Verbal fluency by category (animals); (ii) Memory using a 10-word list; (iii) Praxias; (iv) Trail Making tests A and B; (v) Montreal Cognitive Assessment (MoCA).
2. Physical performance assessed using the Short Physical Performance Battery (SPPB).
3. Body composition assessed using single-frequency bioelectrical impedance (BIA) using RJL equipment.
4. Muscle strength assessed using a Jamar handheld hydraulic dynamometer with a measurement range of 0 to 100 kg.
5. Biochemical markers of oxidative stress and inflammation: total pro-oxidant capacity, total antioxidant capacity, and markers of chronic inflammation (IL-1, IL-6, IL-8, IL-10, TNF-α).
All measured at 12 months
Secondary outcome measures1. Psychological variables and sleep: depressive symptoms, sleep, well-being, and quality of life will be assessed according to standardized protocols at the Gerontology Research Unit.
2. Advanced activities of daily living: The questionnaire to assess advanced activities of daily living developed by Dias et al. (2019) will be administered.
All measured at 12 months
Overall study start date04/02/2024
Completion date31/12/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit60 Years
Upper age limit74 Years
SexBoth
Target number of participants120 (40 participants per group)
Key inclusion criteria1. Adults aged 60 to 74 years.
2. No uncontrolled chronic non-communicable diseases.
3. No severe cognitive problems assessed with the Montreal Cognitive Assessment (MoCa) scale.
4. No terminal illnesses.
5. Sedentary in the past 6 months (less than 60 minutes of moderate-intensity aerobic activity per week and no regular resistance training).
Key exclusion criteria1. Older adults who do not wish to participate in the study.
2. Who do not have signed informed consent.
3. With uncontrolled chronic non-communicable diseases.
4. With limitations in physical or cognitive functional capacity.
Date of first enrolment06/06/2024
Date of final enrolment18/09/2024

Locations

Countries of recruitment

  • Mexico

Study participating centre

Gerontology Research Unit, FES Zaragoza (Unidad de Investigación en Gerontología, FES Zaragoza, UNAM).
Batalla 5 de Mayo s/n esquina Fuerte de Loreto, Colonia Ejército de Oriente, Iztapalapa
Mexico City
09230
Mexico

Sponsor information

Universidad Nacional Autónoma de México
University/education

(FES Zaragoza, UNAM).General Management of Academic Personnel Affairs (DGAPA), UNAM. PAPIIT Project: IN307424
Batalla 5 de Mayo s/n esquina Fuerte de Loreto, Colonia Ejército de Oriente, Iztapalapa
Mexico City
09230
Mexico

Phone +52 55 5623-0721
Email coordinacion.investigacion@zaragoza.unam.mx
Website https://www.zaragoza.unam.mx/investigacion/unidades-investigacion/ui-gerontologia/
ROR logo "ROR" https://ror.org/01tmp8f25

Funders

Funder type

University/education

Universidad Nacional Autónoma de México
Government organisation / Local government
Alternative name(s)
National Autonomous University of Mexico, UNAM
Location
Mexico

Results and Publications

Intention to publish date20/11/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planScientific article in a peer-reviewed journal with impact factor.
IPD sharing planDatasets generated or analyzed during this study will be included in the subsequent publication of the results.

Editorial Notes

15/05/2025: Trial's existence confirmed by Research Ethics Committee of the FES Zaragoza, UNAM.