NCT05016089

Brief Summary

This study aims to examine the efficacy of the simplified Pilates exercise programme developed by a group of Pilates and rehabilitation experts in Hong Kong to reduce the risk of falling (the physical and psychological risk factors) of Hong Kong's older adults who might be prone to falling. It is hypothesized that a simplified Pilates exercise programme is efficacious in reducing the risk of falling (the physical and psychological risk factors) in Hong Kong's older adults who are at a medium to high risk of falling. There is no updated research that has specifically investigated an expertly designed simplified Pilates exercise programme and no research investigated it in Hong Kong as well. Therefore, this study is novel and important in investigating the efficacy of an expertly designed simplified Pilates exercise programme in Hong Kong's older population specifically developed for reducing the risk of falls. It could increase the intelligent choices of efficacious and easy-to-comply-with fall prevention exercise programmes (the 16-style simplified Pilates exercise programme) for older adults and reduce the impact of falls in the older population. The more the choices of simple and efficacious fall prevention programmes that are available for older adults, the more likely it is that they will be interested in complying with the programme. Consequently, this research could provide evidence of Pilates being used in fall prevention of older adults locally and globally.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

August 11, 2021

Last Update Submit

November 17, 2022

Conditions

Keywords

EfficacySimplified PilatesWait-list controlFalls preventionOlder adultsRisk of fallingFall risk factorsHong Kong

Outcome Measures

Primary Outcomes (2)

  • Baseline Balance Ability

    Berg Balance Scale (BBS)

    Day 0

  • Change from Baseline Balance Ability at 12 weeks

    Berg Balance Scale (BBS)

    Week 12

Secondary Outcomes (16)

  • Baseline Flexibility

    Day 0

  • Change from Baseline Flexibility at 12 weeks

    Week 12

  • Baseline Functional Gait and Balance Assessment

    Day 0

  • Change from Baseline Functional Gait and Balance Assessment at 12 weeks

    Week 12

  • Baseline Functional Gait Assessment

    Day 0

  • +11 more secondary outcomes

Study Arms (2)

Simplified Pilates exercise group (SPEG)

EXPERIMENTAL

The participants in the SPEG will participate in the 16-style simplified Pilates exercise sessions (about 60 minutes each) in a group (about 10 participants in each group) twice a week for 12 weeks. Each participant will undertake a total of 24 exercise sessions.

Other: The 16-style simplified Pilates exercise programme

Wait-list control group (WLCG)

OTHER

The participants in the WLCG will participate in the 16-style simplified Pilates exercise sessions (about 60 minutes each) in a group (about 10 participants in each group) twice a week for 12 weeks after two scheduled assessment sessions and a waiting period of 12 weeks in between. Each participant will undertake a total of 24 exercise sessions.

Other: The 16-style simplified Pilates exercise programme

Interventions

The 16-style simplified Pilates exercise programme was developed by a group of experienced Pilates and rehabilitation experts from our completed pilot work.

Simplified Pilates exercise group (SPEG)Wait-list control group (WLCG)

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 or above;
  • score of less than 24/28 in the Tinetti Performance Oriented Mobility Assessment (POMA).

You may not qualify if:

  • total score of less than 24 in the Chinese version of the Mini-Mental State Examination (MMSE-C);
  • presence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit;
  • presence of any unstable medical condition that can affect safety during the exercise training;
  • inability to sit and lie down on a Pilates exercise mat on the floor even with assistance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

Study Officials

  • Thomson Wong, PhD, BScPT

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomson Wong, PhD, BScPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised, controlled (wait-list control), and two-armed trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 23, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations