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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aging, Functional Status

Intervention / Treatment
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* Behavioral: Physical training
* Behavioral: Cognitive training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical and cognitive exercise group<br>Participants will be randomized to receive physical and cognitive training for a period of 12 weeks. | Behavioral: Physical training<br>* 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<br>Behavioral: Cognitive training<br>* 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<br>|
| Active Comparator: Physical exercise only group<br>Participants will be randomized to receive only physical training for a period of 12 weeks. | Behavioral: Physical training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | 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. | Baseline (weeks 0) to Post-training (week 13) | 
| 30-s Sit-to-Stand test performance | 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. | Baseline (weeks 0) to Post-training (week 13) | 
| World Health Organization Quality of Life-bref (WHOQOL-bref) score | 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. | Baseline (weeks 0) to Post-training (week 13) | 
| Beck's Depression Inventory (BDI) score | The BDI is a self-administered questionnaire covering cognitive, affective, behavioral, and somatic aspects of depression. | Baseline (weeks 0) to Post-training (week 13) | 
| Canadian Occupational Performance Measure (COPM) | 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. | Baseline (weeks 0) to Post-training (week 13) | 
| Digit Span Test (DST) | The DST will be used to evaluate participants' working memory. | Baseline (weeks 0) to Post-training (week 13) | 
| Verbal fluency test | Participants' verbal fluency will me assessed by asking participants to name as many different animals as they know in one minute. | Baseline (weeks 0) to Post-training (week 13) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Cognitive training, Aging, Frailty, Occupational performance