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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical and cognitive exercise group | Experimental | Participants will be randomized to receive physical and cognitive training for a period of 12 weeks. |
|
| Physical exercise only group | Active Comparator | Participants will be randomized to receive only physical training for a period of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristine L Alberton, PhD | Federal University of Pelotas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escola Superior de Educação FÃsica | Pelotas | Rio Grande do Sul | 96055-630 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37599360 | Derived | 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. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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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.
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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.
|
| 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 |
|
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) |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |