Effect of Strength Training and Whole Body Vibration in Healthy Elderly

NCT01526109 | Withdrawn DMC

• 1 other identifier: 040.2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

elderly; quality of life; functional capacity; cognitive function; physical exercise

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks

  The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality (energy and fatigue), perception of general health.

  from date to randomization at 12 weeks

Secondary Outcomes (7)

• Change from baseline in Senior Fitness Test at 12 weeks

  from date to randomization at 12 weeks

• Change from baseline in American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test at 12 weeks

  from date to randomization at 12 weeks

• Change from baseline in Trail Making Test at 12 weeks

  from date to randomization at 12 weeks

• Change from baseline in Mini Metal State Examination (MMSE) at 12 weeks

  from date to randomization at 12 weeks

• Change from baseline in Digit Test at 12 weeks

  from date to randomization at 12 weeks

Study Arms (3)

strength training group

EXPERIMENTAL

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).

Behavioral: Strength training group

Control group

PLACEBO COMPARATOR

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

Behavioral: Control group

whole-body vibration training group

EXPERIMENTAL

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 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.

Behavioral: Whole-body vibration training group

Interventions

Strength training group BEHAVIORAL

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).

Also known as: resistence training

strength training group

Control group BEHAVIORAL

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

Also known as: no intensity

Control group

Whole-body vibration training group BEHAVIORAL

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 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.

Also known as: WBV training

whole-body vibration training group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Gama Filho: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Universidade Gama Filho

Rio de Janeiro, Rio de Janeiro, 20740-900, Brazil

Location

MeSH Terms

Conditions

Health Behavior; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Andrea Deslandes, Dr

  UGF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2012-02

Locations

BR (1)