Clinical trial NCT05016089: Simplified Pilates Training in Older Adults in Hong Kong
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aged
Keywords: Efficacy
Simplified Pilates
Wait-list control
Falls prevention
Older adults
Risk of falling
Fall risk factors
Hong Kong
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Education University of Hong Kong
First posted: 2021-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, controlled (wait-list control), and two-armed trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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;
4. inability to sit and lie down on a Pilates exercise mat on the floor even with assistance.

Primary outcomes:
measure: Baseline Balance Ability
timeFrame: Day 0
measure: Change from Baseline Balance Ability at 12 weeks
timeFrame: Week 12
Secondary outcomes:
measure: Baseline Flexibility
timeFrame: Day 0
measure: Change from Baseline Flexibility at 12 weeks
timeFrame: Week 12
measure: Baseline Functional Gait and Balance Assessment
timeFrame: Day 0
measure: Change from Baseline Functional Gait and Balance Assessment at 12 weeks
timeFrame: Week 12
measure: Baseline Functional Gait Assessment
timeFrame: Day 0
measure: Change from Baseline Functional Gait Assessment at 12 weeks
timeFrame: Week 12
measure: Preliminary Cognitive Function
timeFrame: Day 0
measure: Baseline Depression Levels
timeFrame: Day 0
measure: Change from Baseline Depression Levels at 12 weeks
timeFrame: Week 12
measure: Baseline Anxiety Levels
timeFrame: Day 0
measure: Change from Baseline Anxiety Levels at 12 weeks
timeFrame: Week 12
measure: Baseline Fear of Falling
timeFrame: Day 0
measure: Change from Baseline Fear of Falling at 12 weeks
timeFrame: Week 12
measure: Baseline Balance Confidence
timeFrame: Day 0
measure: Change from Baseline Balance Confidence at 12 weeks
timeFrame: Week 12
measure: Frequency of falls
timeFrame: Week 12
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Thomson Wong, PhD, BScPT
role: PRINCIPAL_INVESTIGATOR
References: