NCT01475448

Brief Summary

The goal of this project is to understand the effect of regular practice of long distance running on the posture and movement control of older adults. For such, the investigators will conduct an experiment with longitudinal design where sedentary elderly individuals will be trained in long distance running for about 4 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 3, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 5, 2015

Status Verified

November 1, 2011

Enrollment Period

7 months

First QC Date

November 3, 2011

Last Update Submit

May 2, 2015

Conditions

Keywords

biomechanicsmotor controlmovementwalkingrunningsedentarismjoint moment

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of posture and movement patterns at 16 weeks

    biomechanical and physiological measures of the posture and movement patterns

    Two weeks before and two weeks after the training for sixteen months

Secondary Outcomes (3)

  • Change from baseline of mechanical joint moments estimated by inverse dynamics at 16 weeks

    Two weeks before and two weeks after the training for four months

  • Change from baseline of muscle activity measured by surface electromyography of selected muscles of the lower limb at 16 weeks

    Two weeks before and two weeks after the training for four months

  • Change from baseline of body sway measured by estabilography with a force plate during standing at 16 weeks

    Two weeks before and two weeks after the training for four months

Study Arms (2)

Sedentary older adults - running

EXPERIMENTAL

Sedentary older adults (60 years old or more) recruited from local community

Other: Long distance training

Sedentary older adults - walking

ACTIVE COMPARATOR

Sedentary older adults (60 years old or more) recruited from local community

Other: Walking training

Interventions

Long distance training during four months, 3 times per week

Sedentary older adults - running

Walking training during four months, three times per week

Sedentary older adults - walking

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary
  • Independent bipedal locomotion

You may not qualify if:

  • Inapt for practicing physical activity
  • Severe alteration of the muscle-skeletal system
  • Cognitive or neurological deficit
  • Use of orthosis for locomotion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Biophysics

São Paulo, São Paulo, 05508030, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marcos Duarte

    Federal University of ABC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 21, 2011

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

May 5, 2015

Record last verified: 2011-11

Locations