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.