Clinical trial NCT05309278: Remote Physical and Cognitive Training Effects in Older Adults at Increased Risk of Clinical-functional Vulnerability
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Functional Status
Keywords: Exercise
Cognitive training
Aging
Frailty
Occupational performance
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Timed Up and Go (TUG) performance
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Dual-task performance
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Mini-Mental State Examination (MMSE) score
timeFrame: Baseline (weeks 0) to Post-training (week 13)
Secondary outcomes:
measure: Handgrip strength
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: 30-s Sit-to-Stand test performance
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: World Health Organization Quality of Life-bref (WHOQOL-bref) score
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Beck's Depression Inventory (BDI) score
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Digit Span Test (DST)
timeFrame: Baseline (weeks 0) to Post-training (week 13)
measure: Verbal fluency test
timeFrame: Baseline (weeks 0) to Post-training (week 13)
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Escola Superior de Educação Física
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Cristine L Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
References: