Effects of a Remote Physical Training Program Combined With Cognitive Training in Older Adults at Increased Risk of Clinical-functional Vulnerability: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- Federal University of Pelotas
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Dual-task performance
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Detailed 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.
Investigators
Cristine Lima Alberton
Principal investigator
Federal University of Pelotas
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Dual-task performance
Time Frame: Baseline (weeks 0) to Post-training (week 13)
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.
Timed Up and Go (TUG) performance
Time Frame: Baseline (weeks 0) to Post-training (week 13)
The TUG test will be used to measure possible modifications in the dynamic balance of older adults during the performance of the task.
Mini-Mental State Examination (MMSE) score
Time Frame: Baseline (weeks 0) to Post-training (week 13)
The MMSE will be used to assess participants' cognitive function, which will be classified based on the education-adjusted cut-off scores.
Secondary Outcomes
- 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))
- Digit Span Test (DST)(Baseline (weeks 0) to Post-training (week 13))
- 30-s Sit-to-Stand test performance(Baseline (weeks 0) to Post-training (week 13))
- Verbal fluency test(Baseline (weeks 0) to Post-training (week 13))
- Handgrip strength(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))