Falls, AccidentalNCT02919514
Effect of Surfaces on Fall in Elderly
A study testing Physical training on hard surface., Physical training on sand surface. and Physical training on soft surface. in people with Falls, Accidental and Aging, run by Khon Kaen University at 1 site in Thailand.
Trial summary
To investigate the effects of Thai dance exercises over 6 weeks on functional outcomes and incidence of fall in community-dwelling older individuals. To compare effects of exercise training on hard, soft and sand surfaces in community-dwelling older individuals Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Falls, Accidental, Aging
- What is being tested?
- Physical training on hard surface., Physical training on sand surface. and Physical training on soft surface.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2015to 30 Sep 2018
- 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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age at least 60 yr old
- fall
Who cannot join
- having pain (VAS >5)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon Kaen University
Multiple Locations, Changwat Khon Kaen, 40002
About this study
Official title: Effects of Physical Training on Hard, Sand and Soft Surfaces on Functional Ability and Incidence of Falls in Elderly With or Without History of Falls
To investigate the effects of Thai dance exercises over 6 weeks on functional outcomes and incidence of fall in community-dwelling older individuals.
To compare effects of exercise training on hard, soft and sand surfaces in community-dwelling older individuals
- Conditions
- Falls, Accidental, Aging
- Being tested
- Physical training on hard surface., Physical training on sand surface., Physical training on soft surface.
- Keywords
- fall prevention, Aging, surfaces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training on hard surface.Other
Physical training on hard surface.
Physical training on sand surface.Other
Physical training on sand surface.
Physical training on soft surface.Other
Physical training on soft surface.
| Study group | Role | What they receive |
|---|---|---|
| Physical training on hard surface | Active comparator | Subject will participate in exercise training on a firm surface for 50 min/session, 3 days/week for 6 weeks in total. Receives: Other: Physical training on sand surface.; Other: Physical training on soft surface. |
| Physical training on sand surface | Experimental | Subject will participate in exercise training on a sand surface for 50 min/session, 3 days/week for 6 weeks in total. Receives: Other: Physical training on hard surface.; Other: Physical training on soft surface. |
| Physical training on soft surface | Experimental | Subject will participate in exercise training on a soft surface for 50 min/session, 3 days/week for 6 weeks in total. Receives: Other: Physical training on hard surface.; Other: Physical training on sand surface. |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test (10MWT)
The 10MWT quantifies walking speed that the results correlate to health status, morbidity rate and mortality rate; hence it has been suggested to be used as an important vital sign of elderly. Subjects walk along a 10meter walkway at a comfortable and fast gait speed. The time used over 4meters in the middle of the walkway will be recorded to minimize acceleration and deceleration effects. The average time required over the 3 trials will be converted to walking speed in m/s.
Measured: 0,3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start15 Nov 2015
- Primary completion30 Mar 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls, AccidentalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, Ph.D., Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919514
- Sponsor's protocol ID
- 2561A10302245
- Status last verified
- Mar 2019
- First submitted
- 23 Sep 2016
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Training on Hard, Sand and Soft Surfaces on Functional Ability and Incidence of Falls in Elderly With or Without History of Falls
- ClinicalTrials.gov ID
- NCT02919514
- Acronym / sponsor ID
- 2561A10302245
- Conditions
- Falls, Accidental, Aging
- Keywords
- fall prevention, Aging, surfaces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
To investigate the effects of Thai dance exercises over 6 weeks on functional outcomes and incidence of fall in community-dwelling older individuals.
To compare effects of exercise training on hard, soft and sand surfaces in community-dwelling older individuals
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical training on hard surface | Active comparator | Other: Physical training on sand surface., Other: Physical training on soft surface.Subject will participate in exercise training on a firm surface for 50 min/session, 3 days/week for 6 weeks in total. |
| Physical training on sand surface | Experimental | Other: Physical training on hard surface., Other: Physical training on soft surface.Subject will participate in exercise training on a sand surface for 50 min/session, 3 days/week for 6 weeks in total. |
| Physical training on soft surface | Experimental | Other: Physical training on hard surface., Other: Physical training on sand surface.Subject will participate in exercise training on a soft surface for 50 min/session, 3 days/week for 6 weeks in total. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age at least 60 yr old
- fall
Key exclusion criteria (1 listed)
- having pain (VAS >5)
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 |
|---|---|---|
| Physical training on hard surface.Physical training on hard surface. | Other | Physical training on sand surface, Physical training on soft surface |
| Physical training on sand surface.Physical training on sand surface. | Other | Physical training on hard surface, Physical training on soft surface |
| Physical training on soft surface.Physical training on soft surface. | Other | Physical training on hard surface, Physical training on sand surface |
Primary outcome
10-meter walk test (10MWT)
Time frame: 0,3 and 6 weeks
The 10MWT quantifies walking speed that the results correlate to health status, morbidity rate and mortality rate; hence it has been suggested to be used as an important vital sign of elderly. Subjects walk along a 10meter walkway at a comfortable and fast gait speed. The time used over 4meters in the middle of the walkway will be recorded to minimize acceleration and deceleration effects. The average time required over the 3 trials will be converted to walking speed in m/s.
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 12 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Sugalya Amatachaya, Ph.D. principal investigator
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training on hard surface., Physical training on sand surface. and Physical training on soft surface. in people with Falls, Accidental and Aging, run by Khon Kaen University at 1 site in Thailand.
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 2 inclusion and 1 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 12 Mar 2019. 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 Thailand. 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?
10-meter walk test (10MWT) (time frame: 0,3 and 6 weeks). 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 12 Mar 2019.