- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016089
Simplified Pilates Training in Older Adults in Hong Kong
The Efficacy of a Simplified Pilates Exercise Training in Reducing the Risk of Falling in Hong Kong's Older Adults: A Wait-list Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomised controlled trial to investigate the efficacy of the simplified Pilates exercise programme (developed by a group of Pilates and rehabilitation experts in Hong Kong in our completed pilot study) by comparing it with the wait-list control.
A total of 60 older adults will be recruited from different collaborating community elderly and rehabilitation centres in Hong Kong using convenience sampling. The inclusion criteria will be the following: (1) age 65 or above and (2) score of less than 24/28 in the Tinetti Performance Oriented Mobility Assessment (POMA). The exclusion criteria will be the following: (1) total score of less than 24 in the Chinese version of the Mini-Mental State Examination (MMSE-C), (2) presence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit, (3) presence of any unstable medical condition that can affect safety during the exercise training, and (4) inability to sit and lie down on a Pilates exercise mat on the floor even with assistance.
The participants (N = 60) will be randomly assigned using concealed block randomisation by an independent person through a sealed and opaque envelope system to either the simplified Pilates exercise group (SPEG; n = 30) or the wait-list control group (WLCG; n = 30). A computerised random-number generator will be utilised to prepare an allocation schedule. The participants in the SPEG will partake in 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. All the training sessions will be conducted in Hong Kong by two experienced and certified Pilates trainers under the supervision of a registered physiotherapist. The participants in the SPEG will practise the 16-style simplified Pilates exercise programme. The WLCG will participate in the 16-style simplified Pilates exercise programme after two scheduled assessment sessions and a waiting period of 12 weeks in between.
To examine the efficacy of the exercise programme, the participants of both the SPEG and WLCG will undergo two assessment sessions before training at baseline (T0) and just after the completion of all the exercise sessions (T1). In the baseline assessment (T0), a structural questionnaire will be used to ask the participants for their demographic information, detailed information regarding any previous falls, detailed medical history, use of prescribed drugs, social history, and socio-economic status. Following this, a series of assessments will be conducted to examine their balance ability, which will be measured by the Berg Balance Scale (BBS; primary outcome measure), and other physical and psychological fall risk factors (secondary outcome measures) in the two assessment sessions (T0 & T1). Any adverse events will be reported and tracked. Participants will also be asked to prospectively record the number of falls they have experienced during the time between T0 and T1 using a structural calendar. The frequency of falls (secondary outcome measure) will then be collected at T1.
Balance ability (primary outcome measure) will be assessed using the BBS. Regarding the other physical fall risk factors (secondary outcome measure), flexibility will be measured using the 'sit-and-reach' (S&R) test. A functional gait and balance assessment will be conducted using the POMA and Timed Up and Go (TUG) tests.
On the other hand, for the assessment of the psychological fall risk factors (secondary outcome measure), the MMSE-C will be used as a screening tool to examine the preliminary cognitive function at the beginning of training. Depression levels will be assessed using the Chinese version of the 4-item Geriatric Depression Scale (GDS-4C). Anxiety levels will be measured using the valid and reliable Chinese version of the State-Trait Anxiety Inventory (STAT-SC & STAI-TC). The valid and reliable Chinese version of the Falls Efficacy Scale International [FES-I (Ch)] will be utilised to assess the fear of falling. The valid and reliable Chinese version of the Activities-Specific Balance Confidence Scale [ABC (Ch)] will be used to evaluate balance confidence.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomson Wong, PhD, BScPT
- Phone Number: (852)27666717
- Email: thomson.wong@polyu.edu.hk
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Thomson Wong, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 65 or above;
- score of less than 24/28 in the Tinetti Performance Oriented Mobility Assessment (POMA).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simplified Pilates exercise group (SPEG)
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.
|
The 16-style simplified Pilates exercise programme was developed by a group of experienced Pilates and rehabilitation experts from our completed pilot work.
|
Other: Wait-list control group (WLCG)
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.
|
The 16-style simplified Pilates exercise programme was developed by a group of experienced Pilates and rehabilitation experts from our completed pilot work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Balance Ability
Time Frame: Day 0
|
Berg Balance Scale (BBS)
|
Day 0
|
Change from Baseline Balance Ability at 12 weeks
Time Frame: Week 12
|
Berg Balance Scale (BBS)
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Flexibility
Time Frame: Day 0
|
Sit-and-reach (S&R) test
|
Day 0
|
Change from Baseline Flexibility at 12 weeks
Time Frame: Week 12
|
Sit-and-reach (S&R) test
|
Week 12
|
Baseline Functional Gait and Balance Assessment
Time Frame: Day 0
|
The Tinetti Performance Oriented Mobility Assessment (POMA)
|
Day 0
|
Change from Baseline Functional Gait and Balance Assessment at 12 weeks
Time Frame: Week 12
|
The Tinetti Performance Oriented Mobility Assessment (POMA)
|
Week 12
|
Baseline Functional Gait Assessment
Time Frame: Day 0
|
Timed Up and Go (TUG) tests
|
Day 0
|
Change from Baseline Functional Gait Assessment at 12 weeks
Time Frame: Week 12
|
Timed Up and Go (TUG) tests
|
Week 12
|
Preliminary Cognitive Function
Time Frame: Day 0
|
The Chinese version of the Mini-Mental State Examination (MMSE-C)
|
Day 0
|
Baseline Depression Levels
Time Frame: Day 0
|
The Chinese version of the 4-item Geriatric Depression Scale (GDS-4C)
|
Day 0
|
Change from Baseline Depression Levels at 12 weeks
Time Frame: Week 12
|
The Chinese version of the 4-item Geriatric Depression Scale (GDS-4C)
|
Week 12
|
Baseline Anxiety Levels
Time Frame: Day 0
|
The Chinese version of the State-Trait Anxiety Inventory (STAT-SC & STAI-TC)
|
Day 0
|
Change from Baseline Anxiety Levels at 12 weeks
Time Frame: Week 12
|
The Chinese version of the State-Trait Anxiety Inventory (STAT-SC & STAI-TC)
|
Week 12
|
Baseline Fear of Falling
Time Frame: Day 0
|
The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)]
|
Day 0
|
Change from Baseline Fear of Falling at 12 weeks
Time Frame: Week 12
|
The Chinese version of the Falls Efficacy Scale International [FES-I (Ch)]
|
Week 12
|
Baseline Balance Confidence
Time Frame: Day 0
|
The Chinese version of the Activities-Specific Balance Confidence Scale [ABC (Ch)]
|
Day 0
|
Change from Baseline Balance Confidence at 12 weeks
Time Frame: Week 12
|
The Chinese version of the Activities-Specific Balance Confidence Scale [ABC (Ch)]
|
Week 12
|
Frequency of falls
Time Frame: Week 12
|
Participants will be asked to prospectively record the number of falls they have experienced during the time between Day 0 and Week 12 using a structural calendar.
The frequency of falls will be collected at Week 12.
|
Week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thomson Wong, PhD, BScPT, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18191091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aged
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingAged | Patient Safety | Aged, 80 and Over | Restraint, PhysicalSpain
-
University Hospital, ToulouseNot yet recruiting
-
Abbott NutritionCompleted
-
Pontificia Universidad Catolica de ChileNot yet recruiting
-
National Yang Ming UniversityCompleted
-
University Hospital, ToulouseFondation pour la Recherche MédicaleCompleted
Clinical Trials on The 16-style simplified Pilates exercise programme
-
Gazi UniversityUnknownAnkylosing SpondylitisTurkey
-
Karolinska InstitutetKarolinska University HospitalCompletedUrinary Bladder CancerSweden
-
Henning BliddalCambridge Weight Plan Limited; Velux Fonden; Oak Foundation; The Danish Rheumatism...CompletedObesity | Osteoarthritis, KneeDenmark
-
Fundació Universitària del BagesRecruitingChild DevelopmentSpain
-
The Hong Kong Polytechnic UniversityRecruitingSarcopenic ObesityHong Kong
-
Hacettepe UniversityCompletedMuscle Weakness | Shoulder Pain | Sport Injury | Upper Extremity InjuryCyprus
-
Yonsei UniversityCompletedHypertension | PrehypertensionKorea, Republic of