NCT02919514

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

September 23, 2016

Last Update Submit

March 10, 2019

Conditions

Falls, AccidentalAging

Keywords

fall preventionAgingsurfaces

Outcome Measures

Primary Outcomes (1)

  • 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.

    0,3 and 6 weeks

Study Arms (3)

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.

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.

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.

Other: Physical training on hard surface.Other: Physical training on sand surface.

Interventions

Physical training on hard surface.OTHER

Physical training on hard surface.

Physical training on sand surfacePhysical training on soft surface
Physical training on sand surface.OTHER

Physical training on sand surface.

Physical training on hard surfacePhysical training on soft surface
Physical training on soft surface.OTHER

Physical training on soft surface.

Physical training on hard surfacePhysical training on sand surface

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age at least 60 yr old
  • fall

You may not qualify if:

  • having pain (VAS \>5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Multiple Locations, Changwat Khon Kaen, 40002, Thailand

Location

Study Officials

  • Sugalya Amatachaya, Ph.D.

    School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 29, 2016

Study Start

November 15, 2015

Primary Completion

March 30, 2018

Study Completion

September 30, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)