- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03521752
Influence of an Exercise Program in the Elderly Balance
Influence of a Specific Exercise Program in the Institutionalized Elderly Balance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 65 years
- institutionalized elderly
- Both genders
- Mini-Mental ≥19 pontos
- Protocol attendance ≥ 90%
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Performed a specific program exercises (resistance training, balance, coordination and flexibility) during 4 weeks.
|
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.
|
|
No Intervention: Control
The control group wasn't subjected to any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional capacity
Time Frame: 4 weeks
|
Timed up and Go (TUG) This scale measures the mobility and locomotor performance, through the timing of an activity (lift from a chair, walk 3 meters, change direction and return to starting position). The cut-off points of the scale are divided into fully independent elderly (<10 seconds), independent elderly (10-19 seconds), and elderly people with difficulties in the tasks of daily living (20-29 seconds). It was evaluated before and after the intervention. |
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1CESPU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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