Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability
- Conditions
- AgingFunctional Status
- Interventions
- Behavioral: Physical trainingBehavioral: Cognitive training
- Registration Number
- NCT05309278
- Lead Sponsor
- Federal University of Pelotas
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 62
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical and cognitive exercise group Physical training Participants will be randomized to receive physical and cognitive training for a period of 12 weeks. Physical exercise only group Physical training Participants will be randomized to receive only physical training for a period of 12 weeks. Physical and cognitive exercise group Cognitive training Participants will be randomized to receive physical and cognitive training for a period of 12 weeks.
- Primary Outcome Measures
Name Time Method Dual-task performance 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 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 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 Outcome Measures
Name Time Method Verbal fluency test Baseline (weeks 0) to Post-training (week 13) Participants' verbal fluency will me assessed by asking participants to name as many different animals as they know in one minute.
Beck's Depression Inventory (BDI) score Baseline (weeks 0) to Post-training (week 13) The BDI is a self-administered questionnaire covering cognitive, affective, behavioral, and somatic aspects of depression.
Canadian Occupational Performance Measure (COPM) Baseline (weeks 0) to Post-training (week 13) The COPM is a semi-structured interview that uses a typical day as a reference to identify issues in self-care, productivity, and leisure based on the self-reported performance capacity and satisfaction of the patient in occupations the participant need, wants, and/or is expected to do.
Digit Span Test (DST) Baseline (weeks 0) to Post-training (week 13) The DST will be used to evaluate participants' working memory.
30-s Sit-to-Stand test performance Baseline (weeks 0) to Post-training (week 13) Lower limb strength will be assessed using the 30-s Sit-to-Stand test, which involves counting the number of times the participant can stand up completely from the sitting position, with arms crossed over the chest.
Handgrip strength Baseline (weeks 0) to Post-training (week 13) The amount of force produced by a maximal isometric contraction of the extrinsic hand muscles of the dominant upper limb will be measured using a hand dynamometer.
World Health Organization Quality of Life-bref (WHOQOL-bref) score Baseline (weeks 0) to Post-training (week 13) The WHOQOL-bref questionnaire covers four domains of quality of life (physical health, psychological health, social relationships, and environment) and will be used to assess self-reported quality of life.
Trial Locations
- Locations (1)
Escola Superior de Educação Física
🇧🇷Pelotas, RS, Brazil