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A Female Specific Anterior Cruciate Ligament Menstrual Cycle Phased Rehab Programme

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000517875
Enrollment
31
Registered
2021-05-03
Start date
2021-08-05
Completion date
2022-11-30
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rates of female anterior cruciate ligament (ACL) injuries have increased in recent years. Results after surgery are inferior for females, and females are more likely to suffer another injury. Quadriceps strength has shown to be able to predict outcomes and further injuries for those who have had ACL reconstruction surgery. Females usually have less quadriceps strength compared to males. Menstrual cycle phased strength training programmes have been shown to increase quadriceps strength and size in females. However, before, this has only been researched in people who don’t have injuries. The purpose of this research is to understand what effect completing certain exercises at certain parts of the menstrual cycle has on the strength of knee muscles and ability for females to use their knee following rehabilitation after ACL reconstruction surgery. 72 females are expected to take part. All participants must be willing to participate in rehabilitation with a physiotherapist for thirty minutes twice a week for twelve weeks, where you will participate in strengthening and other exercises. All participants must also be willing to track their menstrual cycle daily for twelve weeks, using a calendar and a thermometer daily and once a month use a urinary ovulation testing kit to confirm when you ovulate. They will be expected to enter this information on a password protected online sheet. In both groups, physiotherapists will measure the strength of the participants' quadriceps at the start and end of the twelve weeks. Also, the participants will have to fill in three questionnaires at the start and end of the twelve weeks. The rehabilitation programme is designed to help participant's recover from their surgery.

Interventions

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 complet

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.

Sponsors

Auckland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Exclusion Criteria: Using the oral contraceptive pill , Allograft/synthetic graft, Cartilage damage > Grade II, Meniscal Repair, Revision surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026