NCT03521752

Brief Summary

This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly. It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

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

May 4, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

10 days

First QC Date

April 18, 2018

Last Update Submit

May 10, 2018

Conditions

Keywords

BALANCEINSTITUTIONALIZED ELDERLY PEOPLETHERAPEUTIC EXERCISEFUNCTIONAL CAPACITY

Outcome Measures

Primary Outcomes (1)

  • Balance

    Performance Oriented Mobility Assessment (POMA) This scale measures the static and dynamic balance, through the evaluation of some daily activities. This scale's scores are between 9 to 28 points, when 9 means hig risk of falling, and 28 means low risk of falling. It was used before and after the intervention.

    4 weeks

Secondary Outcomes (1)

  • Functional capacity

    4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Performed a specific program exercises (resistance training, balance, coordination and flexibility) during 4 weeks.

Other: Specific Exercise Program

Control

NO INTERVENTION

The control group wasn't subjected to any intervention

Interventions

4 weeks of exercise classes, 2 to 3 times a week for a total of 10 sessions. Classes last approximately 40 minutes. The sessions included balance training, motor strength, endurance and flexibility. The training sessions were divided into warm-up, main activity and finally relaxation.

Experimental

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • institutionalized elderly
  • Both genders
  • Mini-Mental ≥19 pontos
  • Protocol attendance ≥ 90%

You may not qualify if:

  • Cardiovascular diseases
  • Contraindication to physical exercise
  • Medication (anxiolytics, antidepressants)
  • Vestibular disorders
  • Previous physiotherapy of 6 months to the present study
  • Neurological and neuromuscular diseases
  • Use of gaiters
  • Another type of physical exercise during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 11, 2018

Study Start

May 4, 2015

Primary Completion

May 14, 2015

Study Completion

June 22, 2015

Last Updated

May 16, 2018

Record last verified: 2018-05