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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-4m3k2c
Date of registration: 10/10/2016
Prospective Registration: No
Primary sponsor: Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Public title: Effects of exercise in the treatment of depression, dementia and parkinson.
Scientific title: Effectiveness of exercise in the treatment of major depression, Alzheimer's disease and Parkinson's disease.
Date of first enrolment: 13/08/2014
Target sample size:
Recruitment status: Recruiting
URL:  http://ensaiosclinicos.gov.br/rg/RBR-4m3k2c
Study type:  Intervention
Study design:  Clinical trial treatment, parallel, open, randomized controlled trial with two arms.  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Andrea Camaz   Deslandes
Address:  Av. Venceslau Braz, 71 - Botafogo 22290-140 Rio de Janeiro Brazil
Telephone: +55 (21) 3938-5506
Email: camazdeslandes@gmail.com
Affiliation:  Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Name: Andrea Camaz   Deslandes
Address:  Av. Venceslau Braz, 71 - Botafogo 22290-140 Rio de Janeiro Brazil
Telephone: +55 (21) 3938-5506
Email: camazdeslandes@gmail.com
Affiliation:  Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Key inclusion & exclusion criteria
Inclusion criteria: Seniors over 60 years. both sexes. diagnosed with major depression. Alzheimer's disease. Parkinson's disease.
Exclusion criteria: Cerebrovascular infarction history. use of treatments such as electroconvulsive therapy. psychotherapy, illiterate and functional class III and IV according to the criteria of the New York Heart Association.

Age minimum:
Age maximum:
Gender: -
Health Condition(s) or Problem(s) studied
F02.3
F06.7
Major Depressive Disorder, Mild Cognitive Impairment, Alzheimer's Disease, Parkinson's Disease
Intervention(s)
I02.233.543
Other
It will be recruited at least 60 patients in each clinical condition (DM, DA and PD), considering the loss of follow-up of 20% (12 patients). Thus, sample reach the N 20 subjects for each type of intervention (physical training and control) and a total of 180 patients during the five years of research (60 DM, 60 AD, 60 PD). The sample size was based on the results of a pilot unpublished study conducted in our laboratory.The control group (C) will have clinical follow-up, but will not perform any physical training. The training group (TG) will attend the Institute of Neurology Deolindo Couto twice a week to conduct a training routine. The routine consists of performing aerobic training (AT) and force (TF) in a 60-minute service session, 30 minutes for each training method. The TF will be done at an intensity of 70% of one repetition maximum (RM). large groups will be used (extensors and knee flexors, dorsal and pectoral), three sets of 8 to 12 repetitions for each muscle group. The TA will be carried out at an intensity of 70% of maximal oxygen consumption (VO2max) or 80% of maximum heart rate (MHR) estimated production, established by the formula 220 - age. equipment will be used as a treadmill for walking or stationary bike. The training will be led by physical education teachers and physiotherapists and will be monitored by the rate monitors Polar ® brand. the blood pressure of the subjects will be measured before, during and after each training session.
Primary Outcome(s)
Reduction of the depressive symptoms for depression group after 3 months; the Geriatric Depression Scale; via response parameters, namely 50% reduction of symptoms after 3 months of the intervention. For the Alzheimer group, the reduction of overall cognitive state performance after 3 months of operation; the Mini-Mental State Examination; it is expected that the reduction of the scores is less than 3 points in the exercise group, ie higher in the control group compared to the exercise group. For Parkinson's group, improved UPDRS score after 3 months.
Secondary Outcome(s)
After 3 months of intervention is expected to improve the functional capacity assessed by the Berg Balance Scale, the test to evaluate the dual task, the test of strength with the use of a dynamometer, by kinematic gait analysis and the battery tests functional Senior Fitness Test. Improvement of electrophysiological activity assessed by heart rate variability and the electroencephalogram; expected increase in HRV and increased alpha power. Improved hormonal response by measuring cortisol and DHEA.
Secondary ID(s)
Source(s) of Monetary Support
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro
Secondary Sponsor(s)
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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