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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04901520
Other study ID # A-GS47732
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date January 25, 2020

Study information

Verified date May 2021
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 25, 2020
Est. primary completion date January 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High Intensity Training
High Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition
Moderate Intensity Training
Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition
Low Intensity Training
Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition

Locations

Country Name City State
Malaysia Fit House Bukit Rimao Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in the Mean of Front Reach Test at 4, 8, and 12 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
Primary Change from Baseline in the Mean of Lateral Reach Test at 4, 8, and 12 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
Primary Change from Baseline in the Mean of One Leg Stand at 4, 8, and 12 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
Primary Change from Baseline in the Mean of Tandem Stand Test at 4, 8, and 12 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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