Healthy AgingNCT04901520
The Effects of Different Intensity Training on Dynamic and Static Balance of Elderly
A study testing High Intensity Training, Moderate Intensity Training and Low Intensity Training in people with Healthy Aging, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- High Intensity Training, Moderate Intensity Training and Low Intensity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2019to 25 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Aging
- Being tested
- High Intensity Training, Moderate Intensity Training, Low Intensity Training
- Keywords
- Older adults, Dynamic Balance, Static Balance, Resistance Training, High-Intensity training, Moderate-Intensity Training, Low-Intensity Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity TrainingOther
High Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition
Moderate Intensity TrainingOther
Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition
Low Intensity TrainingOther
Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Training (HIT) | Experimental | Participants trained at 80-90% of 1RM for 12 weeks, twice per week. Receives: Other: High Intensity Training |
| Moderate Intensity Training (MIT) | Experimental | Participants trained at 65-75% of 1RM for 12 weeks, twice per week. Receives: Other: Moderate Intensity Training |
| Low Intensity Training (LIT) | Experimental | Participants trained at 50-60% of 1RM for 12 weeks, twice per week. Receives: Other: Low Intensity Training |
| Control Group (CG) | No intervention | Participants did not participate in any training and they advised to do their daily activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 4th weeks, 8th weeks, 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Oct 2019
- Primary completion25 Jan 2020
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 3 intervention groups and one control group, assessed in 4 different times (baseline, 4th, 8th, and 12th weeks of intervention)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamran Hosseinzadeh Ghasemabad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901520
- Sponsor's protocol ID
- A-GS47732
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Intensity Training on Dynamic and Static Balance of Elderly Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04901520
- Acronym / sponsor ID
- A-GS47732
- Conditions
- Healthy Aging
- Keywords
- Older adults, Dynamic Balance, Static Balance, Resistance Training, High-Intensity training, Moderate-Intensity Training, Low-Intensity Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 3 intervention groups and one control group, assessed in 4 different times (baseline, 4th, 8th, and 12th weeks of intervention)
| Arm | Type | Receives |
|---|---|---|
| High Intensity Training (HIT) | Experimental | Other: High Intensity TrainingParticipants trained at 80-90% of 1RM for 12 weeks, twice per week. |
| Moderate Intensity Training (MIT) | Experimental | Other: Moderate Intensity TrainingParticipants trained at 65-75% of 1RM for 12 weeks, twice per week. |
| Low Intensity Training (LIT) | Experimental | Other: Low Intensity TrainingParticipants trained at 50-60% of 1RM for 12 weeks, twice per week. |
| Control Group (CG) | No intervention | –Participants did not participate in any training and they advised to do their daily activity |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity TrainingHigh Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition | Other | High Intensity Training (HIT) |
| Moderate Intensity TrainingModerate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition | Other | Moderate Intensity Training (MIT) |
| Low Intensity TrainingLow Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition | Other | Low Intensity Training (LIT) |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Training, Moderate Intensity Training and Low Intensity Training in people with Healthy Aging, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.