Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000517875
Ethics application status
Approved
Date submitted
31/03/2021
Date registered
3/05/2021
Date last updated
23/09/2022
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Female Specific Anterior Cruciate Ligament Menstrual Cycle Phased Rehab Programme
Scientific title
A randomised controlled trial to evaluate the effect of a menstrual cycle phased rehabilitation programme on quadriceps extension strength for females post Anterior Cruciate Ligament reconstruction
Secondary ID [1] 303832 0
None
Universal Trial Number (UTN)
U1111-1265-6004
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament injury
 321354 0
Condition category
Condition code
Musculoskeletal 319132 319132 0 0
Other muscular and skeletal disorders
Injuries and Accidents 319464 319464 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 319465 319465 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Menstrual Cycle Phased Anterior Cruciate Ligament Reconstruction Rehabilitation
Aim: The study is aiming to investigate if menstrual cycle phased Anterior Cruciate Ligament reconstruction rehabilitation results in superior outcomes as compared to usual care Anterior Cruciate Ligament Reconstruction rehabilitation.
What: The intervention provider (physiotherapists) will receive a booklet, which will explain how to correctly measure the outcome measures, the specific exercises to complete, along with a guide to confirm menstrual cycle phase and periodise exercises to the participants' menstrual cycle phase.
The participants will be sent a basal body thermometer and a urinary ovulation prediction kit. Once the patient reaches six weeks post operation, they will commence completing their rehab exercises in line with their menstrual cycle phases. Over the twelve weeks of the study the participants in the intervention group will have to confirm their menstrual cycles. Participants will track their cycle via a calendar every day ie. mark the days they have their menses, take their basal body temperature every morning, and once a month, confirm their ovulation by using a urinary prediction kit. They will enter these details into a password protected individual data collection Google Sheet.
After the twelve week intervention outcome measures will be remeasured.
Who provided: Physiotherapists will be providing the intervention. These will be physiotherapists who regularly see post-operative anterior cruciate ligament reconstruction patients. They will have been given the information booklet which has been designed specifically for this study, and attended a training session with the primary investigator. This training session will be given over Zoom for 2 hours in small groups (maximum number 6 physios) which will include interactive activities to consolidate learning given in the information sheet and short videos to demonstrate exercises and outcome measurement taking.
How: This intervention will be provided to the participant individually, face to face. The participants will be given a physiotherapy clinic to attend.
When and how much: On initial assessment, at six weeks post operation, the physiotherapist will measure the outcome measures. Participants in the intervention group will attend their physiotherapy appointments in a physiotherapy clinic (which must have access to gym equipment including leg press and leg extension machines) for a 30-minute-long session twice a week for twelve weeks (24 sessions).
Tailoring: Throughout the twelve week intervention, the participants in the intervention group will complete their rehabilitation strength exercises (moderate to vigorous intensity, as measured by Borg Rate of Perceived exertion scale and guided by physiotherapist) in the follicular phase of their own personal menstrual cycle. They will then complete cardiovascular exercises (eg. walking, cycling) and neuromuscular exercises eg., Toe Stand/Toe Walk/Wobble Board Stand/Single Leg Stand exercises (moderate to vigorous intensity, as measured by Borg Rate of Perceived exertion scale and guided by the treating physiotherapist) in the luteal phase of their own personal menstrual cycle.
Intervention code [1] 320151 0
Rehabilitation
Comparator / control treatment
Name: Usual Care Anterior Cruciate Ligament Rehabilitation
Aim: The study is aiming to investigate if menstrual cycle phased Anterior Cruciate Ligament reconstruction rehabilitation results in superior outcomes as compared to usual care Anterior Cruciate Ligament Reconstruction rehabilitation.
What: The intervention provider (physiotherapists) will receive a booklet, which will explain how to correctly measure the outcome measures, along with a guide to confirm menstrual cycle phase and general principles of anterior cruciate ligament rehabilitation (usual care).
The participants will be sent a basal body thermometer and a urinary ovulation prediction kit. Over the twelve weeks of the study the participants in the intervention group will have to confirm their menstrual cycles. Participants will track their cycle via a calendar every day ie. mark the days they have their menses, take their basal body temperature every morning, and once a month, confirm their ovulation by using a urinary prediction kit. They will enter these details into a password protected individual data collection Google Sheet.
The participants will be given a physiotherapy clinic to attend. After the twelve week intervention outcome measures will be remeasured.
Who provided: Physiotherapists will be providing the control intervention. These will be physiotherapists who regularly see post-operative anterior cruciate ligament patients. They will have been given the information booklet, and attended a training session with the primary investigator.
How: This intervention will be provided to the participant individually, face to face.
When and how much: On initial assessment at six weeks post operation, the physiotherapist will measure outcome measures(strength, self reported function and self efficacy). Participants in the control group will attend their physiotherapy appointments in a physiotherapy clinic (which must have gym equipment or access) for a 30-minute-long session twice a week for twelve weeks (24 sessions).
Tailoring: Throughout the twelve week intervention, the participants in the control group will complete their rehabilitation exercises throughout their menstrual cycle as normal. The same exercises that were prescribed to the intervention group will be prescribed to participants in the control group without timing the regime to the participant's menstrual cycles. Strength exercises will include leg press, squat and leg extension exercises at moderate to vigorous intensity, as measured by Borg Rate of Perceived exertion scale and guided by physiotherapist. Cardiovascular exercises will include walking and cycling and neuromuscular exercises will include Toe Stand/Toe Walk/Wobble Board Stand/Single Leg Stand exercises at low to moderate intensity, as measured by Borg Rate of Perceived exertion scale and guided by the treating physiotherapist. Menstrual cycle monitoring will still occur, to verify that they are regularly menstruating, and therefore are an appropriate control group.
How Well: Adherence to the programme will be monitored on a password protected Google Sheet to be completed by the participant and physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 327042 0
The primary outcome will be limb symmetry index (%) of maximum quadriceps strength of injured versus uninjured leg as measured in kilograms by a one-repetition-maximum test on a leg extension machine.
Timepoint [1] 327042 0
First appointment of the twelve week programme (6 weeks post operatively)
Final appointment of the twelve week programme (18 weeks post operatively)
Secondary outcome [1] 393581 0
Self-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score questionnaire. and the International Knee Documentation Committee questionnaire.
Timepoint [1] 393581 0
First appointment of the twelve week programme (6 weeks post operatively)
Final appointment of the twelve week programme (18 weeks post operatively)
Secondary outcome [2] 393582 0
Self-efficacy assessed using the Knee Self Efficacy Scale.
Timepoint [2] 393582 0
First appointment of the twelve week programme (6 weeks post operatively)
Final appointment of the twelve week programme (18 weeks post operatively)

Eligibility
Key inclusion criteria
Females 16 years old or older who have undergone anterior cruciate ligament surgery and have a regular menstrual cycle. Females who are using a copper IUD will be included. Females will also be included who use the progestin dosed IUD (the Mirena), however they must using the progestin dosed IUD for over one year.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: Using the oral contraceptive pill , Allograft/synthetic graft, Cartilage damage > Grade II, Meniscal Repair, Revision surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done by; Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be completed by simple randomisation using a randomisation table created by computer software Research Randomizer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the purpose of the study, the sample size estimation was conducted with several considerations. Based on the results of a previous study by Harput et al. (2019) estimated strength measures at pre intervention are 1.2±0.5 Newton metres per kilogram (Nm/kg) and demonstrating an increase of 1.2 Nm/kg post training for a standard strength-training programme. Assuming a standard error of 0.5 with a sample size of 16, which relates to a standard deviation of 2 (note it was not stated whether standard deviation or standard error was produced in the article so it has been assumed to be standard error). From Reis et al. (1995) it was demonstrated that menstrual phase-based training produced a 33% increase in strength performance versus a 13% increase for regular training. Utilising these figures it is estimated that with a level of 0.05 and 90% power a sample size of 27 in each group will enable the detection of a difference of 2.0 Nm/kg between the two groups. Considering some feedback has been given regarding the reliability of the strength measures for these types of participants, numbers have been boosted by 10% to 30 in order to account for this. Assuming a drop out rate of 20%, a recruitment target would be 36 per group.

All statistical analyses will be conducted using Open Source Software ‘R’. Initial patient characteristics including age, BMI and other characteristics will be presented as descriptive statistics (mean and standard deviation or percentage, depending on the factor of the variable). The dependent variables will be maximum isometric quadriceps strength and
KOOS scores. The independent variable will be whether the client is in the intervention group or not. Normality of distributions will be examined using the Kolmogorov-Smirnov test. A two factor (time and group) ANOVA will be utilised for this study. The 2 factors will be time (pre and post intervention), which was the repeated measure, and group (experimental and control). In the case of non-normality a Wilcoxon signed-rank test or a general linear model would be used using the appropriate distribution. In all cases P values <.05 will indicate statistical significance. Considering this is a real-life, in clinic protocol, it is expected there may be some participants’ lost to follow up during the course of the randomised control trial. Therefore, per protocol analysis will be completed after the trial, which will exclude all those who did not complete the protocol, adhere to the protocol, or missed measurements. Reasons for these will be noted by the coordinating investigator and reported in the final report.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
5/08/2021
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
72
Accrual to date
31
Final
Recruitment outside Australia
Country [1] 23575 0
New Zealand
State/province [1] 23575 0
Auckland, Wellington, Tauranga, Christchurch, New Plymouth, Hamilton, Wanaka

Funding & Sponsors
Funding source category [1] 308227 0
University
Name [1] 308227 0
Auckland University of Technology
Country [1] 308227 0
New Zealand
Funding source category [2] 308241 0
Charities/Societies/Foundations
Name [2] 308241 0
New Zealand Manipulative Physiotherapists' Association
Country [2] 308241 0
New Zealand
Funding source category [3] 308242 0
Government body
Name [3] 308242 0
The Accident Compensation Corporation
Country [3] 308242 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Level 2, AUT Millennium
17 Antares Place
Rosedale
Auckland 0632
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309017 0
Individual
Name [1] 309017 0
Emma O'Loughlin
Address [1] 309017 0
Auckland University of Technology,
Level 2,
AUT Millennium,
17 Antares Place,
Rosedale,
Auckland 0632,
New Zealand
Country [1] 309017 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308209 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308209 0
Ethics committee country [1] 308209 0
New Zealand
Date submitted for ethics approval [1] 308209 0
24/03/2021
Approval date [1] 308209 0
28/05/2021
Ethics approval number [1] 308209 0
Ethics committee name [2] 309471 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 309471 0
Ethics committee country [2] 309471 0
New Zealand
Date submitted for ethics approval [2] 309471 0
28/05/2021
Approval date [2] 309471 0
25/06/2021
Ethics approval number [2] 309471 0
21/203

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109938 0
Ms Emma O'Loughlin
Address 109938 0
Auckland University of Technology,
Level 2,
AUT Millennium,
17 Antares Place,
Rosedale,
Auckland 0632,
New Zealand
Country 109938 0
New Zealand
Phone 109938 0
+64221723949
Fax 109938 0
Email 109938 0
[email protected]
Contact person for public queries
Name 109939 0
Emma O'Loughlin
Address 109939 0
Auckland University of Technology,
Level 2,
AUT Millennium,
17 Antares Place,
Rosedale,
Auckland 0632
New Zealand
Country 109939 0
New Zealand
Phone 109939 0
+64 221723949
Fax 109939 0
Email 109939 0
[email protected]
Contact person for scientific queries
Name 109940 0
Duncan Reid
Address 109940 0
Room AG 108,
90 Akoranga Drive,
Faculty of Health and Environmental Sciences,
AUT University,
Private Bag 92006,
Auckland,
1142
Country 109940 0
New Zealand
Phone 109940 0
+6421473545
Fax 109940 0
Email 109940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only deidentified data will be available, including demographic data, menstrual cycle verification data, outcome measures including strength, and patient reported function and self efficacy, as per the ethics consent process.
When will data be available (start and end dates)?
This data will be available once the trial is completed and the main results have been published, for 10 years, as was outlined in the ethics application.
Available to whom?
This will be available to all consented participants, to all involved in the research team, and on a case by case basis at the discretion of the Primary Investigator
Available for what types of analyses?
Statistical analysis to achieve the aims in the proposal.
How or where can data be obtained?
Data can be obtained via the Primary Investigator, Emma O'Loughlin at [email protected]


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.