Clinical trial NCT01983397: Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years
Official title: Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Oldest Old: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary
Keywords: aged, 80 and over
Exercise
Cognition
Balance
Randomized controlled trial
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 69
Sex: ALL
Minimum age (years): 80
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of different trainings on cognition and physical performances in elderly over 80 years.

Detailed description: Purpose: To compare the effects of 16-week multicomponent and resistance trainings on cognition and physical performances related to falls in oldest old people living in community; to analyze the same variables after 6-week detraining. Method: We conducted a randomized controlled trial with 69 community elderly over 80 years, sedentary and without cognitive disorder. Participants were allocated to control, multicomponent training or resistance training group. The multicomponent group performed a protocol involving warm-up, aerobic, strength, balance and cool-down exercises. The resistance group underwent to strength exercises using six machines: leg press, chest press, calf, back extension, abdominal and rowing. The control group did not perform any intervention. The trainings had progressive intensity, lasted 16 weeks and included three 1-hour sessions per week. The participants were evaluated at baseline, at the end of 16-week training and at 6-week detraining. The assessment consisted of anamnesis, depression (Geriatric Depression Scale), cognition (Montreal cognitive assessment), dual task walking (associated to cognitive and motor tasks), balance (unipedal and tandem tests), strength of lower limbs (sit-to-stand test) and history of falls. For statistical analysis by intention to treat, we adopted a significance level of α=0.05.

Eligibility criteria: Inclusion Criteria:

* age between 80 and 95 years old
* live in community
* sedentary lifestyle
* ability to walk without help from another person with/without aid walking

Exclusion Criteria:

* any cardiovascular or infectious comorbidity described in the absolute contraindications of the Physical Activity Readiness Medical Examination
* Relative contraindications of cognitive, neurological and/or musculoskeletal comorbidities which make participation in protocols impossible
* Score in mini-state examination mental below the cutoff score designated by education level.

Primary outcomes:
measure: Changes from baseline in lower limbs strength after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
measure: Changes from baseline in balance after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
measure: Changes from baseline in dual task walking after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
measure: Changes from baseline in cognition after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining.
Secondary outcomes:
measure: Changes from baseline in number of falls after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
measure: Changes from baseline in depression after 16 weeks of training and 6 weeks of detraining
timeFrame: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Juliana H Ansai, specialist
role: PRINCIPAL_INVESTIGATOR
References: