- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04901520
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
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Kuala Lumpur, Malaysia
- Fit House Bukit Rimao
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Training (HIT)
Participants trained at 80-90% of 1RM for 12 weeks, twice per week.
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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.
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Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition
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|
Experimental: Low Intensity Training (LIT)
Participants trained at 50-60% of 1RM for 12 weeks, twice per week.
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Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition
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No Intervention: Control Group (CG)
Participants did not participate in any training and they advised to do their daily activity
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What is the study measuring?
Primary Outcome Measures
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
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Baseline, 4th weeks, 8th weeks, 12th weeks
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|
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
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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
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Baseline, 4th weeks, 8th weeks, 12th weeks
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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
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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
|
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2019
Primary Completion (Actual)
January 25, 2020
Study Completion (Actual)
January 25, 2020
Study Registration Dates
First Submitted
May 20, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 25, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID 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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