Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000182594
Ethics application status
Approved
Date submitted
25/10/2023
Date registered
26/02/2024
Date last updated
26/02/2024
Date data sharing statement initially provided
26/02/2024
Date results information initially provided
26/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of Clinical Pilates exercises on pain and function
Scientific title
Acute effects of brief session of Clinical Pilates exercise on pain, function and other physical outcomes in young adults with chronic lower back pain.
Secondary ID [1] 310846 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 331881 0
Condition category
Condition code
Musculoskeletal 328601 328601 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be prescribed exercises according to Dance Medicine Australia (DMA) Clinical Pilates method (supported by Australian Physiotherapy Association). A physiotherapist will be supervising the session, one-on-one. This is a single session intervention of 30 minutes (inclusive of directional preference assessment). The mat-based exercises prescribed will be specific for each participant based on his/her movement directional preference to achieve physical performance improvements. The exercises will be of low to moderate exercise intensity using Borg RPE 1-10 scale.
Examples of flexion preference exercises include cat stretch, bug legs and scissors, while examples of extension preference exercises include bridging, prone single leg kick and quadruped (leg). Lateral flexion preference exercises include mermaid and side lunges. Rotation preference exercises include bug roll (flexion) and attitude rotation (extension).
Intervention code [1] 327257 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336406 0
Pain
Timepoint [1] 336406 0
Baseline and immediately post-intervention
Primary outcome [2] 336407 0
Function
Timepoint [2] 336407 0
Baseline and immediately post-intervention
Secondary outcome [1] 428180 0
Knee extensor strength
Timepoint [1] 428180 0
Baseline and immediately post-intervention
Secondary outcome [2] 428181 0
Flexibility
Timepoint [2] 428181 0
Baseline and immediately post-intervention
Secondary outcome [3] 430159 0
Hip extensor strength
Timepoint [3] 430159 0
Baseline and immediately post-intervention
Secondary outcome [4] 430160 0
Hip abductor strength
Timepoint [4] 430160 0
Baseline and immediately post-intervention
Secondary outcome [5] 430161 0
Flexibility
Timepoint [5] 430161 0
Baseline and immediately post-intervention

Eligibility
Key inclusion criteria
- Aged 21 years and above;
- Chronic low back pain lasting for at least three months;
- Pain on most days of the week ranging from 3 to 7 out of 10.
Minimum age
21 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lower-limb injuries (past 6 weeks);
- Surgery (past 12 weeks);
- Lower limb fractures (past 6 months);
- Neurological or inflammatory joint conditions;
- End-stage illnesses;
- Cognitive or visual impairments;
- Ongoing fever or infection;
- Unexplained weight loss or loss of appetite;
- Loss of bladder or bowel control, or saddle paresthesia;
- Known pregnancy at point of screening;
- Received prescribed exercise intervention in the past 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
9/07/2022
Date of last data collection
Anticipated
Actual
9/07/2022
Sample size
Target
34
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 25921 0
Singapore
State/province [1] 25921 0

Funding & Sponsors
Funding source category [1] 315097 0
University
Name [1] 315097 0
Singapore Institute of Technology
Country [1] 315097 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Dr S138683
Country
Singapore
Secondary sponsor category [1] 317117 0
None
Name [1] 317117 0
Address [1] 317117 0
Country [1] 317117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314039 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 314039 0
10 Dover Dr S138683
Ethics committee country [1] 314039 0
Singapore
Date submitted for ethics approval [1] 314039 0
05/07/2021
Approval date [1] 314039 0
14/08/2021
Ethics approval number [1] 314039 0
2021026

Summary
Brief summary
The study explores the benefits of a brief Clinical Pilates exercise session for adults with chronic low back pain. Self-reported pain and function are recommended outcomes to evaluate success of intervention. Physical outcomes of hip and knee strength, as well as lower back and hip flexibility will be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130210 0
Mr Kwok Boon Chong
Address 130210 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 130210 0
Singapore
Phone 130210 0
+6596916703
Fax 130210 0
Email 130210 0
kwokboonchong@gmail.com
Contact person for public queries
Name 130211 0
Mr Kwok Boon Chong
Address 130211 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 130211 0
Singapore
Phone 130211 0
+6596916703
Fax 130211 0
Email 130211 0
kwokboonchong@gmail.com
Contact person for scientific queries
Name 130212 0
Mr Kwok Boon Chong
Address 130212 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 130212 0
Singapore
Phone 130212 0
+6596916703
Fax 130212 0
Email 130212 0
kwokboonchong@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Personal Data Protection Act restriction


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.