The Effects of Different Intensity Training on Dynamic and Static Balance of Elderly

May 27, 2021 updated by: Kamran Hosseinzadeh Ghasemabad, Universiti Putra Malaysia

The Effects of Different Intensity Training on Dynamic and Static Balance of Elderly Women: A Randomized Controlled Trial

In this study, investigators tried to find a useful and safe way of training for the elderly population which can help this population to improve their fitness factors as fast as possible. investigators have tried to see if different intensity training has different effects on the dynamic and static balance of elderly women in different time points (4, 8, and 12 weeks). Investigators hypothesized that Higher intensity would be more effective to improve balance at different time points. The participants were trained twice per week and each session contain 4 exercises ( leg press, leg extension, leg curl, and seated calf raises) and the data have been collected at the pre-test and 4th, 8th, and 12th weeks of intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Fit House Bukit Rimao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Aged 65 years old and above.
  • Orientation to place, time, and person, able to follow the simple instructions, and perform the exercises.
  • Without any health problems that would interfere with their safety or ability to complete high and low-intensity training such as the occurrence of myocardial infarction in the past six months, recent heart attack, uncontrolled hypertension (Blood Pressure >166/96 mm Hg), a broken leg in the past six months, diagnosed osteoporosis, and diagnosed stage three and four of heart failure.

Exclusion Criteria:

  • Participation in regular balance or lower body resistance training during the past three months (at least twice per week).
  • The health issues that might confound the study results, including lower- body neuropathy, stroke within the past year, Parkinson's disease, diagnosed vestibular disorders, severe vision (self-rated vision as poor or very poor even when wearing glasses or contact lenses), and lower- extremity joint replacements.
  • Taking the regular medication's impairing balance ability (Antidepressants, Neuroleptics or Benzodiazepines) or muscle strength (Corticosteroids).
  • Elderly with dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Intensity Training (HIT)
Participants trained at 80-90% of 1RM for 12 weeks, twice per week.
Other: High Intensity Training
High Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition
Experimental: Moderate Intensity Training (MIT)
Participants trained at 65-75% of 1RM for 12 weeks, twice per week.
Other: Moderate Intensity Training
Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition
Experimental: Low Intensity Training (LIT)
Participants trained at 50-60% of 1RM for 12 weeks, twice per week.
Other: Low Intensity Training
Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition
No Intervention: Control Group (CG)
Participants did not participate in any training and they advised to do their daily activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Mean of Front Reach Test at 4, 8, and 12 weeks
Time Frame: Baseline, 4th weeks, 8th weeks, 12th weeks
The distance that subject can lean forward measured in centimetre (cm) with measuring tape. The higher score is better. The minimum is 5 cm and maximum 50 cm
Baseline, 4th weeks, 8th weeks, 12th weeks
Change from Baseline in the Mean of Lateral Reach Test at 4, 8, and 12 weeks
Time Frame: Baseline, 4th weeks, 8th weeks, 12th weeks
The distance that subject can lean to the side measured in centimetre (cm) with measuring tape. The higher score is better. Minimum is 5 cm and maximum is 50 cm
Baseline, 4th weeks, 8th weeks, 12th weeks
Change from Baseline in the Mean of One Leg Stand at 4, 8, and 12 weeks
Time Frame: Baseline, 4th weeks, 8th weeks, 12th weeks
The timed that subject can stand in 1 leg recorded in second using a stop watch. The higher score is better. minimum is 1 second and maximum is 30 second
Baseline, 4th weeks, 8th weeks, 12th weeks
Change from Baseline in the Mean of Tandem Stand Test at 4, 8, and 12 weeks
Time Frame: Baseline, 4th weeks, 8th weeks, 12th weeks
The timed that subject can stand one leg front and one leg back condition recorded in second using a stop watch. The higher score is better. Minimum is 1 second and maximum is 30 second
Baseline, 4th weeks, 8th weeks, 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-GS47732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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