Clinical trial NCT01526109: Effect of Strength Training and Whole Body Vibration in Healthy Elderly
Official title: Effect of Strength Training and Whole Body Vibration on Cognitive Function, Behavioral and Functional Capacity in Healthy Elderly.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Health Behavior
Keywords: elderly
quality of life
functional capacity
cognitive function
physical exercise
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2012-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Quality of Life (Qol) is a complex concept which relates to the perception of subjective satisfaction, especially in elderly population. It also relates to the self-perception of psychological status, independence level, to the social relationships, and to the environment where the elderly person lives. Consequently, there are a number of factors which may change the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity, and the rupture of social relationship, as well as the aging process itself. Physical exercise is associated to improvement of mental and physical health. However, few studies investigated the effect of strength training and whole- body vibration training on elderly subjects. Following this line of reasoning, the purpose of the present study is to assess the effect of physical exercise on cognition and functional abilities in elderly subjects. Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a control group (CG). Main outcome measures: Cognitive function will be assessed using Mini Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness Test, American Alliance for Health, Physical Education, Recreation \& Dance(AAHPERD)functional fitness test, and Short Form 36(SF-36) health survey.

Detailed description: Design: Three-month controlled, randomized, and double-blind study. The subjects will be recruited from the Gama Filho University. They will be randomized with a blind design to a whole-body vibration training group (WBV), strength training group (STG) and control group (CG) by a researcher who will not participate of the initial assessments.

Intervention

The study is a longitudinal randomized clinical trial. The subjects will perform three visits to the laboratory where they will be submitted to neuropsychological, behavioral and physical evaluations. These evaluations will be performed before and after three months of training. Each visit will last about an hour and a half. After a period of one week of adaptation, subjects begin training with the charges set out in this study. All groups will carry out training twice a week, forty minutes, for three months. Next, will be described in detail the experimental procedures in each group:

STG Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts).

WBV Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration training twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk.

Control Group Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity.

Eligibility criteria: Inclusion Criteria:

* elderly (\> 60 years)
* without diagnosis of mental illness or cognitive decline
* literate
* have not committed to physical exercises.

Exclusion Criteria:

* scored outside the cutoff point set in the scales of depressive symptoms (Beck \> 18)
* cognitive decline (MSSE \< 18 for low educational level and \< 24 for high school).

Primary outcomes:
measure: Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks
timeFrame: from date to randomization at 12 weeks
Secondary outcomes:
measure: Change from baseline in Senior Fitness Test at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: Change from baseline in American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: Change from baseline in Trail Making Test at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: Change from baseline in Mini Metal State Examination (MMSE) at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: Change from baseline in Digit Test at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: change from baseline in Stroop Test at 12 weeks
timeFrame: from date to randomization at 12 weeks
measure: Change from baseline in Rey Complex Figure Test at 16 weeks
timeFrame: from date to randomization at 12 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Gama Filho
Study officials:
affiliation: UGF
name: Andrea Deslandes, Dr
role: PRINCIPAL_INVESTIGATOR
References: