NCT04068376

Double-task Exercise in Older Adults at Risk of Cognitive Decline (MeMo-Health-Cog-3 Program)

Active, enrolled NA Last updated 19 June 2025

What this trial tests

NA trial testing Control excercise in Cognitive Decline in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 May 2023

Primary endpoint
1 December 2025

1 December 2026

Quick facts

Lead sponsor	Instituto Mexicano del Seguro Social
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	300
Start date	1 May 2023
Primary completion	1 December 2025
Estimated completion	1 December 2026
Sites	1 location across Mexico

Drugs / interventions tested

• Control excercise
• "Mind and Movement for Cognitive Health in the Older Adult"
• Double-task exercise by older adults and their caregivers

Conditions studied

• Cognitive Decline — all drugs for Cognitive Decline →
• Vascular Health — all drugs for Vascular Health →

Sponsor

Instituto Mexicano del Seguro Social — full company profile →

Who can join

Adults 60 to 65, any sex, with Cognitive Decline or Vascular Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cerebral small vessel disease is a frequent cause of cognitive disability among older adults (OAs) in Mexico that imposes a significant burden on the health system and OAs' families. We have called the program Mind and Movement for Cognitive Health (MeMo-Salud-Cog-3). Programs to prevent or delay OAs' cognitive decline are scarce. Methods and analysis: A double-blind, randomized clinical trial will be conducted. The study will aim to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for OAs at risk of cognitive decline-one program with and another without caregiver participation-and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 65 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups. The intervention will last 24 weeks, and the effect of each program will be evaluated 12, 24, and 52 weeks after the intervention. Participants' demographic and clinical characteristics will be collected at baseline. The outcomes will include: (i) general cognitive function; (ii) specific cognitive functions; (iii) dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) OAs' health-related quality of life; and (viii) caregiver burden. We will estimate differences in outcomes between each intervention group and the control group at baseline and follow-up evaluations. We will assess differences-in-differences (D-in-D) treatment effects using a D-in-D estimator. If we identify statistically significant differences in participants' baseline characteristics between the groups, we will adjust the D-in-D estimators by these covariates using generalized linear regression models. Ethics and dissemination: The study was approved by the IMSS Ethics and Research Committee (registration number 2018-785-095). All participants will sign a consent form prior to their participation. The study results will be disseminated to IMSS authorities, healthcare providers and the research community.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Double-task exercise programmes to strengthen cognitive and vascular health in older adults at risk of cognitive decline: protocol for a randomised clinical trial.
   Sánchez-Arenas R, Doubova SV, Bernabe-Garcia M, Gregory MA, et al · · 2020 · cited 5× · PMID 33380479 · DOI 10.1136/bmjopen-2020-039723