NCT04348539

Brief Summary

The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 25, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 2, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

March 25, 2020

Last Update Submit

April 1, 2021

Conditions

Keywords

LocomotionAgingTrainingPhysical FitnessGaitQuality of lifeHealth

Outcome Measures

Primary Outcomes (4)

  • Dynamic Balance

    Dynamic balance: Timed Get Up and Go test (distance of 3 meters), which give the time (seconds) that the individual takes to complete the path of the test as fast as possible (without running).

    Change from baseline at 16 weeks

  • Strength

    Lower limb strength: Test to get up and sit on the chair. The individual sits on the chair, with his arms crossed over his chest and at the signal starts the repetitions of getting up and sitting down for a total of 30 seconds. The number of repetitions the subject is able to perform is added.

    Change from baseline at 16 weeks

  • Cardiorespiratory endurance

    cardiorespiratory endurance: 6-minute test. The individual will walk in a 30 meters course for 6 minutes as fast as he can, without running, resulting in the distance covered in that interval.

    Change from baseline at 16 weeks

  • Static balance

    Static balance: force platform by means of the displacement rate of the centre of mass in the anteroposterior (Fx), medium-lateral (Fy) and vertical (Fz) axes. The older people must climb on the platform and unite their feet, keeping their gaze in a fixed linear point, the test will last for 30 seconds, it will be registered with the eyes open and closed

    Change from baseline at 16 weeks

Secondary Outcomes (14)

  • Locomotor Rehabilitation Index

    Change from baseline at 16 weeks

  • Self-selected walking speed

    Change from baseline at 16 weeks

  • Anthropometric data - Body mass

    Change from baseline at 16 weeks

  • Depressive symptoms

    Change from baseline at 16 weeks

  • Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey

    Change from baseline at 16 weeks

  • +9 more secondary outcomes

Other Outcomes (3)

  • Sociodemographic characteristics

    Change from baseline at 16 weeks

  • Cognitive function

    Change from baseline at 16 weeks

  • Lower limb flexibility

    Change from baseline at 16 weeks

Study Arms (4)

Balance training

EXPERIMENTAL

The balance training consists of 3 moments: warm up, main and stretch. Warm-up with mobility exercises for major joints and large muscle groups. The main part will have eight exercise stations divided into: a) five balance exercises (dynamic and static with or without object balance) on a varied floor, b) three agility exercises, and a stretching of the worked muscle groups and a final relaxation.

Other: Balance training

Strength training

EXPERIMENTAL

Muscle strength training will consist of 3 moments: warm up, main and stretch. Warm up with mobility exercises for the main joints and large muscle groups. The main part will include strength exercises with lower and upper limbs with two sets of 6-12 repetitions according to periodization, and a stretching of the muscle groups worked

Other: Balance training

Cardiorespiratory endurance training

EXPERIMENTAL

The older people walking training consists of 3 moments: warm up, main and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed, then walk according to the training cycle, and then a stretching of the main muscle groups. Will be held, twice a week for 45 minutes each session. The training intensity will follow 60-110% of the volume of the 6-minute Test (6MWT) and the Borg Scale at moderate to difficult intervals. the training

Other: Balance training

Control group

NO INTERVENTION

control group: who will receive educational lectures on health, walking and aging.

Interventions

32 sessions will be held twice a week, with each session taking an average of 45 minutes

Also known as: Strength training, Cardiorespiratory endurance training
Balance trainingCardiorespiratory endurance trainingStrength training

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteers
  • aged over 60 years
  • both sexes
  • not performing regular physical activity with professional monitoring

You may not qualify if:

  • not participate in all stages of the evaluation
  • severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
  • stroke or other associated neurological diseases; insanity;
  • prostheses in the lower limbs;
  • without ambulation conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690200, Brazil

Location

Related Publications (1)

  • GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017

    BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Leonardo Alexandre Peyré-Tartaruga, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Central Study Contacts

Leonardo Alexandre Peyré-Tartaruga, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 16, 2020

Study Start

May 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

April 2, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations