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

NCT05309278 | Completed

• 1 other identifier: 55791522.6.0000.5313
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Functional Status

Keywords

Exercise; Cognitive training; Aging; Frailty; Occupational performance

Outcome Measures

Primary Outcomes (3)

• Timed Up and Go (TUG) performance

  The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.

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

• Dual-task performance

  The TUG test will also be applied with a dual task, in which participants' functional capacity will be assessed while simultaneously performing a verbal task. Specifically, the participants will perform the same procedures explained in the TUG test session, while also pronouncing the maximal number of animal names as possible.

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

• Mini-Mental State Examination (MMSE) score

  The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.

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

Secondary Outcomes (7)

• Handgrip strength

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

• 30-s Sit-to-Stand test performance

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

• World Health Organization Quality of Life-bref (WHOQOL-bref) score

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

• Beck's Depression Inventory (BDI) score

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

• Canadian Occupational Performance Measure (COPM)

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

Study Arms (2)

Physical and cognitive exercise group

EXPERIMENTAL

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

Behavioral: Physical training; Behavioral: Cognitive training

Physical exercise only group

ACTIVE COMPARATOR

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

Behavioral: Physical training

Interventions

Physical training BEHAVIORAL

Older adults assigned to this group will undergo two weekly sessions of remote and supervised physical training at home for 1 hour on non-consecutive days. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures

Physical and cognitive exercise group; Physical exercise only group

Cognitive training BEHAVIORAL

These participants will also perform a weekly remote and supervised cognitive training session with neurobic exercises for 1 hour. In addition to the supervised cognitive training session, participants will also be prescribed asynchronous neurobic exercises to be performed on the remaining days of the week (without supervision). The intervention will last for 12 weeks, and all asynchronous neurobic exercises will be recorded in the following synchronous sessions by the supervisor. All synchronous meetings will be held on Google Meet, and supervisors will undergo training to standardize their procedures

Physical and cognitive exercise group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (1)

• Berni FC, Kanitz AC, Miranda C, de Oliveira DB, Bergamin M, Bullo V, Schaun GZ, Alberton CL. Effects of a remotely supervised physical training program combined with cognitive training for older individuals at increased risk of clinical-functional vulnerability: study protocol for a randomized clinical trial. Trials. 2023 Aug 21;24(1):547. doi: 10.1186/s13063-023-07567-8.

  PMID: 37599360 DERIVED

MeSH Terms

Conditions

Motor Activity; Frailty

Interventions

Physical Conditioning, Human; Cognitive Training

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cristine L Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be implemented for the outcome assessors. Specifically, all tests, assessments, and measurements will be performed by an investigator blinded to the group participants were assigned to. Because of the type of intervention (i.e., exercise intervention), the investigator(s) who will carry out the exercise sessions, as well as the participants, won't be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a randomized, single-blind, parallel, controlled, superiority trial. Older participants will be allocated into two groups, experimental and control, based on a randomization sequence that will be generated on a computer in a 1:1 ratio.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: July 26, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 8, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)