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Behind the Scenes of our World-First Fitness and Gender-Affirming Hormone Therapy Study

Updated: 6 days ago

Authors: Eli Ward-Smith and Dr Sav Zwickl.


Content Warning: This blog contains reference to exclusion of, and discrimination against, trans people in sport, and mention of minor medical procedures.


 

In recent years, significant attention has been directed to trans and gender diverse (trans) people in sport. Misinformation and disinformation about trans athletes are rife, and this has been highly damaging to trans people and their allies.


Part of the challenge in contesting this misinformation and disinformation is the lack of scientific evidence regarding whether gender affirming hormone therapy (GAHT) has a positive or negative impact on athletic performance. Our recently published reviews on the impact of GAHT on physical performance and sports participation clearly outline the limitations and gaps in research in this area.


This lack of evidence has allowed the spread of misinformation in the media about trans people in sport to continue, and sporting bodies have developed policies based on opinion rather than evidence.


 

What are we doing to address the gap in research?


In response to the lack of high quality and longer-term research on the impact of GAHT, researchers from the Institute of Health and Sport at Victoria University teamed up with Trans Health Research for The GAME Study (The effects of Gender Affirming hormone therapy on skeletal Muscle training and Epigenetics). Conducted in Melbourne, Australia, this world-first study aims to uncover the effects of GAHT on skeletal muscle health, fitness, and performance. You can read more about the research protocol here.


 

A person standing outdoors with long brown hair and brown eyes, smiling happily

Dr Patrice Jones from Victoria University, the leading researcher on The GAME Study.


Who is leading The GAME Study?


Dr Patrice Jones is the lead researcher on The GAME Study. She is a Postdoctoral Research Fellow in the Genetics, Epigenetics and Exercise group at the Institute for Health and Sport at Victoria University. Motivated by the desire to “build more knowledge in an area that desperately needs it”, Patrice has been running the day-to-day of the study ever since it started.


Patrice describes how the study is “generating new knowledge to be able to answer the HOW question (how do we best include, engage and support trans people in sports/physical activity), not the polarising yes-no trans inclusion questions that are often in the media – it's more complex than that and access to sports/active spaces is not up for debate for anyone”.


As part of her role, Patrice guides participants through multiple study visits over 12 months. As this study involves trans people newly started on gender-affirming hormone therapy, they are all experiencing significant changes in their body and their broader lives.


“I know to expect physical changes in a person after 6, 12 months, but didn’t expect to be able pick up on changes in their presence, confidence, mood," reflects Patrice.


“Seeing people again after some time, as a brighter version of themselves, I feel lucky to be able to witness that."

Patrice adds that running The GAME Study has been a joy, “one of the biggest day-to-day drivers for me are our participants”. Bonds often develop between the researchers and participants; “we get participants from different backgrounds and walks of life, and I enjoy getting to know people and catching up over time. I’ll always remember a chat we had about hobbies/interests, work, study etc, and it’s sad to say goodbye after 12 months.“


 

A person cycling on a stationary bike while two doctors stand nearby, monitoring the person's cycling

A participant on a stationary bike, wearing a mask that measures oxygen/carbon dioxide levels.

 

What does participation in The GAME Study involve?


The GAME Study follows trans adults aged 18-65 years who are about to commence GAHT to explore the effects of GAHT on skeletal muscle health, fitness, and performance over the first 12 months of treatment. The study also involves comparator groups; cisgender or trans people not using hormones that complete the same assessments over 12 months. This study welcomes participants of all fitness levels, with the assessments set to the individuals fitness levels so participants will not be asked to do things beyond their ability.


People interested in participating in the study will discuss with a researcher what is involved, the risks and potential benefits, and any questions they may have. Prior to deciding about their participation, the person will be invited to discuss the study with their friends/family and complete a medical history questionnaire.


Once the person’s medical history is complete and reviewed, and they have been assessed as eligible to participate, the first step in the study will be to arrange for the person’s first study visit (1.5 hours) with a researcher. This first visit is an informal ‘no pressure’ visit, where the person and the researcher complete recruitment/consent forms and the person is shown around the research space and taken through a familiarisation session of the fitness tests involved in the study (described further below) at the specialised private fitness facility at either Victoria University or Monash University. This first visit gives the person an opportunity to see the space and get an idea of what they will be asked to do for the study, before they return to do these fitness tests formally. It also gives the researchers an opportunity to ensure the assessments are comfortable for the person and aligned with their fitness levels.


Following this initial visit, the participant will attend the same fitness facility at Victoria University or Monash University for the baseline assessment, over 3 examination days – each appointment will last 1-2 hours and be spaced at least 48 hours apart (appointments involving muscle biopsies will be scheduled 72 hours post other assessment days).


A white x ray bed with a blue cushion, sitting in the corner of a room

The DEXA scan bed used in this study.


The appointment schedule will be as follows.


Visit 1: Aerobic fitness: Cycling on a stationary bike at increasing resistance, while wearing a mask that measures oxygen/carbon dioxide levels, and a heart rate monitor.

Visit 2: Muscle strength: Standing lower body muscle body muscle strength exercises that use own body weight (no heavy weights), completed while standing on a plate that measures force/strength.

Visit 3: Blood collection and muscle biopsy at rest, and body composition measurements (optional): The blood test is taken from a vein (usually in the arm), using a needle attached to a vacuum device and blood collection tubes. The muscle biopsies are taken under local anaesthetic by a doctor, from the vastus lateralis muscle (the outside part of the thigh above the knee), involving a small incision (approx. 5mm) being made in the numbed area of the leg. Following this, a muscle sample, no larger than the size of a pea, will be taken from the numbed area using a needle. The procedure should be painless, but some people may experience some discomfort/pressure for around 5-10 seconds. The person can expect some tenderness in the day following the biopsy but can do their general activities as usual following the procedure. Body composition assessments via a DEXA scan involve laying on a bed for 5-min while an x-ray arm passes over the participant - results do not have to be shared with the participant if desired.

The Day 3 visit is optional and needs to be completed before an individual starts gender-affirming hormones. If this isn’t possible, or if a participant prefers not to do the muscle biopsy, they can participate in day 1 and 2 visits only.


To control for the impact of diet, an individualised diet is provided for 48 hours prior to muscle and blood sampling, and 24-hour dietary information is collected prior to baseline, 6- and 12-month assessments. During baseline assessment, participants will also be asked to complete some short online questionnaires on your typical physical activity and dietary habits.


During the fitness tests, participants can wear whatever clothes they are comfortable exercising in, with gender-neutral bathrooms available.


These assessments are repeated at 6 and 12 months. The only difference is that the body composition scan is only conducted at Visits 1 (Baseline) and 3 (12 months).


 

What are the benefits for participants?


This study involves a significant commitment from participants. While it might not suit everyone, those people who decide to participate will have a unique opportunity to measure some of the ways in which their body is changing in the first year of GAHT. The study staff will talk through fitness and body composition results if the participant is interested, and they can take home a copy of their results. Equally, results don’t have to be shared with participants if they prefer.


This is also a world-first study, so participants will be contributing to research that is likely to have a significant impact on a global scale.


Participants also receive a $200 visa gift card if taking part in all three days, or $150 if taking part in day 1 and day 2 (fitness test only). Meals are also provided before some study visits.


 

How is data going to be used?


As part of the process of consenting to being involved in the study, participants are told about how their data from the study will be collected, stored, and used.


We also work to share our research findings as widely as possible, to enhance the health and wellbeing of trans people, and to inform the development of policy and guidelines that aim to encourage regular physical activity in trans people.


Privacy and confidentiality are very important to many in the trans community. We ensure that our data is always de-identified. This means that information that could make a participant identifiable (e.g., name, birthdate) are never shared publicly. Additionally, an individual’s data will not be published, only group level data. All data collected is stored in a secure database at Victoria University.


 

I am interested in being part of The GAME Study. Who do I contact?


The GAME Study is currently recruiting. The first step is that we need your consent. The Participant Information and Consent Forms for trans people starting gender-affirming hormone therapy and for people joining the comparator group (cisgender people and trans people not using hormones) are available for download.


For more information or to participate, email Kylie King at gender-research@unimelb.edu.au or call 045166 1295.


For much more in-depth information about The GAME Study, the Research Protocol is publicly available.


 

About the authors


Eli Ward Smith is a critical care registered nurse and senior research officer, with a background in psychology. They are trans non-binary.


Dr Sav Zwickl is a trans non-binary Research Fellow with the Trans Health Research group. They have a Masters degree in Sexology, a PhD in Gender, Sexuality and Diversity Studies, and experience in LGBTIQA+ peer support.

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