Study design and subjects
This is a randomized, controlled, blind trial, conducted between May to
September 2017 according to the criteria of the revised Consolidated
Standards of Reporting Trials (CONSORT)16 2010
statement for reporting randomized trials. Eligible subjects were
elderly 60 years or older residing in Senhor do Bonfim (BA), in the
northeast region of Brazil, recruited throughout the community. The
inclusion criteria were aged ≥ 60 years and who has not exercised
regularly for at least three months prior to the beginning of the study.
According to the Mini-Mental State Examination17,
elderly people with cognitive impairment were excluded, and who
presented any clinical condition that contraindicated the performance of
regular physical exercise, identified through a clinical and
physiotherapeutic evaluation.
This study follows the principles and ethical codes conformed to the
Declaration of Helsinki and, has been approved by the Research Ethics
Committee Involving Human Beings of the Bahian School of Medicine and
Public Health and registered in Registro Brasileiro de Ensaios Clínicos
(REBEC) (Identifier: RBR-3cqzfy). All participants agreed to participate
and signed the free and informed consent form. After an initial
evaluation, with the verification of the inclusion criteria and signing
the informed consent form, the elderly who would participate in the
study were randomly distributed (www.randomizer.org) forming a control
group (CG) and a group that will submit the intervention (IG). According
to our previously published protocol,18 participants
attended a lecture explaining all the study procedures and will also
receive an educational booklet with information on activities of daily
living (ADL’s) related to food, hydration and sleep hygiene. After the
guidance on the ADL’s, the subjects of the IG participated in a training
on how to execute the physical exercise protocol at home.
The elderly received a pedagogical booklet with illustrations of the
exercises and a diary to record the frequency of weekly activities.
After verifying the elderly’s learning how to correctly perform the home
exercise program, guidance was given to family members to help and
encourage regular practice of the exercise program at home. Any clinical
and / or physical changes should be communicated to the researchers
responsible for the program. Guidance was also given to the elderly in
the CG regarding the execution of ADL’s and maintenance of life habits.
Systematized training of five assistants was carried out, exclusively
for evaluations, and ten assistants were involved for home monitoring of
elderly, five of them visited the IG and the other five visited the CG.