NCT02516189

Brief Summary

The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 3, 2015

Last Update Submit

August 11, 2016

Conditions

Keywords

MicrocirculationElectromyographyMotor Activity

Outcome Measures

Primary Outcomes (3)

  • Change in elderlies's microcirculatory blood flow after 4 months

    The blood flow in the microcirculation in the elderly will be measured by laser-doppler flowmetry. The measures blood flow in the microcirculation will be quantified by the reactive hyperemia Post-occlusion protocol (PORH).

    4 months

  • Change in elderlies's muscle fatigue after 4 months

    muscle fatigue will be quantified by surface electromyography of the muscles of the lower limbs. The electromyographic fatigue threshold and fatigue index will be calculated by the Root Mean Square (RMS) and Median Frequency variables after 4 months.

    4 months

  • Change in elderlies's functional capacity after 4 months

    The functional capacity of the elderly will be evaluated by the Berg Balance Scale, the Timed up-and-go Test, and Falls Efficacy Scale International (FES-I) after 4 months

    4 months

Secondary Outcomes (2)

  • Change in elderlies's strength after 4 months

    4 months

  • Change in elderlies's functional autonomy after 4 months

    4 months

Study Arms (2)

Group A

EXPERIMENTAL

group of elderly participants of strength training program

Other: Strength training program

Group B

NO INTERVENTION

group of seniors who did not practice strength training program

Interventions

Strength Training program applied twice a week for sixteen weeks. Each training exercises has a total time of 50 minutes. Warm-up: 5 minutes of stretching. Training: Leg press; Leg Curl; Vertical traction; Chest press; Abdominal crunch; Lower back. Gametherapy. Relaxation: 5 minutes of stretching.

Group A

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • sedentary elderly
  • individuals who have physical and medical conditions to perform strength training
  • individuals who participate in the Open University Maturity Program

You may not qualify if:

  • individuals who do not have physical and medical conditions to perform strength training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Danilo A Vasconcelos, MS

    Universidade Estadual da Paraiba

    PRINCIPAL INVESTIGATOR
  • João G Alves, PhD

    Instituto de Medicina Integral Professor Fernando Figueira

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Director

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08