CompletedNot Applicable

Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability

Brazil26 participantsStarted 2022-07-26

Plain-language summary

This study is a randomized, single-blind, parallel, controlled, superiority trial. The main objective is to verify the chronic effects of a remote 12-week low-intensity physical training program alone or in combination with cognitive training on functional, cognitive, and occupational capacity, as well as on the self-reported quality of life.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 60 years of age or older, * MMSE score equal to or greater than 19 points, * Elementary school education complete or over, * Sedentary (no current or previous participation in structured exercise (\>1x/week) in the past 6 months), * Increased risk of clinical-functional vulnerability, as determined by the Clinical-Functional Vulnerability Index-20 (IVCF-20) questionnaire. * Access to a cell phone or notebook with internet access, * Resident in the city of Pelotas, Brazil. Exclusion Criteria: * Individuals who have been affected by COVID-19, * Not retired, or those retired individuals who maintained continuous or sporadic work activities, * Neuromuscular deficits or any medical diagnosis that prevents the individuals from performing physical exercises, * Individuals with decompensated or untreated blood pressure (\> than 140x90 mmHg) and, * Individuals with visual problems that prevent them from watching the training sessions on their cell phone or notebook screen.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Timed Up and Go (TUG) performance

Timeframe: Baseline (weeks 0) to Post-training (week 13)

Dual-task performance

Timeframe: Baseline (weeks 0) to Post-training (week 13)

Mini-Mental State Examination (MMSE) score

Timeframe: Baseline (weeks 0) to Post-training (week 13)

Trial details

NCT IDNCT05309278

SponsorFederal University of Pelotas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.