NCT04901520

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 20, 2021

Last Update Submit

May 27, 2021

Conditions

Keywords

Older adultsDynamic BalanceStatic BalanceResistance TrainingHigh-Intensity trainingModerate-Intensity TrainingLow-Intensity Training

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

High Intensity Training (HIT)

EXPERIMENTAL

Participants trained at 80-90% of 1RM for 12 weeks, twice per week.

Other: High Intensity Training

Moderate Intensity Training (MIT)

EXPERIMENTAL

Participants trained at 65-75% of 1RM for 12 weeks, twice per week.

Other: Moderate Intensity Training

Low Intensity Training (LIT)

EXPERIMENTAL

Participants trained at 50-60% of 1RM for 12 weeks, twice per week.

Other: Low Intensity Training

Control Group (CG)

NO INTERVENTION

Participants did not participate in any training and they advised to do their daily activity

Interventions

High Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition

High Intensity Training (HIT)

Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition

Moderate Intensity Training (MIT)

Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition

Low Intensity Training (LIT)

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fit House Bukit Rimao

Kuala Lumpur, Malaysia

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 3 intervention groups and one control group, assessed in 4 different times (baseline, 4th, 8th, and 12th weeks of intervention)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

October 1, 2019

Primary Completion

January 25, 2020

Study Completion

January 25, 2020

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations