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

Federal University of Pelotas

Status: Completed

Conditions: Aging; Functional Status

Treatments: Behavioral: Cognitive training; Behavioral: Physical training

Study type: Interventional

Funder types: Other

Identifiers

NCT05309278

55791522.6.0000.5313

Details and patient eligibility

About

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.

Full description

Participants over 60 years of age at increased risk of clinical-functional vulnerability will be recruited in the city of Pelotas/RS, Brazil and randomized to two different arms. The intervention group will receive low-intensity physical training combined with a cognitive training program using neurobic exercises, whereas the active comparator group will only receive the low-intensity physical training program. Participants from both groups will perform their training sessions remotely for a total of 12 weeks. Outcomes of interest include handgrip strength, functional and cognitive capacity, occupational performance, clinical-functional vulnerability level, self-reported quality of life, and depressive symptoms, which will be assessed in a pre-post fashion. The study hypothesis is that remote low-intensity physical training combined with cognitive training will result in additional benefits to those of low-intensity physical training alone in the physical and cognitive capacity outcomes, and as a consequence, improved quality of life, occupational performance, decreased level of clinical-functional vulnerability and symptoms of depression will be observed.

Enrollment: 26 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Physical and cognitive exercise group

Experimental group

Description:

Participants will be randomized to receive physical and cognitive training for a period of 12 weeks.

Treatment:

Behavioral: Physical training

Behavioral: Cognitive training

Physical exercise only group

Active Comparator group

Description:

Participants will be randomized to receive only physical training for a period of 12 weeks.

Treatment:

Behavioral: Physical training