Mental Health IssueNCT05587270
CLIMB: Climbers' Longitudinal Attitudes to Injuries, Mental Health and Body Image
An observational study of Mental Health Issue and Musculoskeletal Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
Eating disorders (ED) are serious mental illnesses with high mortality rates and significant impact on an individual's quality of life. These disorders are characterized by preoccupation of weight and shape, leading to restrictive eating behavior and compensatory behaviors (purging and excessive/compulsive exercise). Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Musculoskeletal Pain, Eating Disorders
- What is being tested?
- Web based surveys and DXA
- Type of treatment
- Surgery or procedure
- How many people
- 366 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older.
Who may be able to join
- Age over 13
- Specific inclusion criteria for the study group:
- Men: completed a boulder route rated harder than 6b or a lead route rated 7a+ within the last three months.
- Women: completed a boulder route rated harder than 6a or a lead route rated 6c within the last year.
Who cannot join
- None
- Previous or current participation on elite level in any sport.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Göteborg University
Gothenburg, Västergötaland, 40530
Mikael Sansone, MD., Ph.D.
Klara Edlund, Ph.D.
About this study
Eating disorders (ED) are serious mental illnesses with high mortality rates and significant impact on an individual's quality of life. These disorders are characterized by preoccupation of weight and shape, leading to restrictive eating behavior and compensatory behaviors (purging and excessive/compulsive exercise). Comorbidities with mental health problems are common. Athletes in leanness-focused sports report higher levels of EDs compared to athletes from sports without such focus . Energy Availability (EA) has been suggested the key variable in "Relative Energy Deficiency in Sports" (RED-S) with studies reporting impairment of reproductive function and bone formation.
Climbing is a weight sensitive sport where athletes generally, benefit from a lean body shape and low weight, a risk factors for ED. Therefore, climbing athletes can be expected to be at high-risk to develop these conditions. To our knowledge, there are no studies on the prevalence and magnitude of EDs among climbers. Due to the overrepresentation of EDs reported in sports and the poor treatment prognosis, early detection and prevention of ED symptoms are essential. The present study will study the prevalence of ED symptoms, changes over time and trajectories of key variables along with related problem areas such as bone health and mental health problems in order to take steps towards tailored strategies for the prevention of EDs in climbing.
The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite vs. sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables over time will be analyzed.
Read the detailed description
Study objectives:
The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite and sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables (with the exception of bone health) over time will be analyzed.
Specific research questions:
- BASELINE
To determine the prevalence of disordered eating behaviors, mental health problems, compulsive training, self-reported symptoms of LEA, overuse injuries and bone density in advanced to elite climbers compared to controls.
Are there gender differences among climbing athletes as far as ED symptoms, body image, compulsive training, perfectionism, mental health problems, sleep quality and overuse injuries?
Do climbing athletes at higher levels of competition (elite vs. advanced) report differing levels of symptoms related to disordered eating behaviors, mental health problems, compulsive training, self- reported symptoms of LEA, overuse injuries and bone density than normal controls?
Are there difference between climbing athletes reporting differences in ED symptoms respectively with regards to bone health as measured by Dual-Energy X-ray Absorptiometry (DXA).
- FOLLOW UP
To study the trajectories of mentioned variables over time and examine the association between modifiable risk factors and ill health and outcome measured by DASS21, EDEQ and OSLO SPORTS OVERUSE INJURIES QUESTIONNAIRE.
Study design:
The study design is longitudinal using a web-based questionnaire with four measures over a two-year period (baseline, 6-, 12- and 24 months) and additional follow-ups at 3 and 5 years after baseline. The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older. There is a minimum of 40 climbers eligible at elite level and a minimum of 80 climbers at sub-elite level of competition. A non-elite athlete control group (n matched of the climbing group) from the general population, will be invited to participate in the study.
In addition to the web-based questionnaire, participants will be invited to the measurement of bone health using DXA at the baseline measurement.
Source population:
The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older.
Sample size: To our knowledge, no previous research has been presented and since the climbing population is small, and the expected outcome measures (ED-symptoms, mental health problems, injuries and bone health) are unknown, we will not be able to carry out power calculations. However, based on similar injury research by one of the co-applicants, a power calculation was estimated on standard deviation of 1.0, significant level set to 0.05, and statistical power 0.80. The study needed 38 participants in each group to detect estimated group differences. We will therefore include at least 40 in each group.
Data collection
The study has been endorsed by the Swedish Climbing Federation. Study information will be distributed via the federation to national teams and clubs asking them to distribute the web-based survey link (computed by the research team) to the climbing athletes and controls. The web-based survey will explain the purpose, aims, and ethical rights, as well as how to complete the questionnaire. Further, information regarding, and an invitation to participate the DXA-scan will be included with this information. Upon electronic consent by both parent and athlete (or just athlete if of consenting age (15 y o a)), access to the multi-section questionnaire will be granted. Contact details of the researchers will be available in case of difficulties comprehending the questions. Following completion, the participants' data will be stored at a secure database for analysis. Participants will be ensured of the confidentiality of the study and will be free to withdraw from the study at any time. Appointments for DXA-scans will be set up after informed consent has been established for the study as a whole.
Exposures
Rock-climbing
Outcomes
Eating Disorders: The Eating Disorders Questionnaire (EDE-Q 6.0) will be used and consists of four subscales: restraint, eating concern, shape concern and weight concern, addressing core dimensions of eating disorders (Berg et al., 2012).
Overuse injuries: The Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O; Clarsen et al., 2020) will be used and measures athlete's self-reported a) participation in sport, b) modified training/competing,c) performance and d) pain in a 4-grades scale from full participation to could not participate due to problems (of injury).
Perfectionism: The Frost Multidimensional Perfectionism Scale (FMPS; Frost, Marten, Lahart \& Rosenblate, 1990) will be used, utilizing the subscales of personal standards (PS) and concern over mistakes (CM).
Compulsive Exercise: Weight loss behaviors and emotion regulation using training is measured with Compulsive Exercise Test (CET; Taranis, Touyz \& Meyer, 2011). The subscales included are: "Weight control exercise" (WCE) and "Avoidance of negative affect and rule driven behavior" (ANARDB).
Body Image: The brief version of the 8 item Body Shape Questionnaire, (BSQ-8C; Welch, Lagerström \& Ghaderi, 2012) will be used.
Symptoms of mental health problems are measured by the Depression Anxiety Stress Scale (DASS-21; Lovibond \& Lovibond, 1995).
Sleep quality: The Pittsburg Sleep Quality Index (PSQI; Carpenter \& Andrykowski,1998) will be used and includes 19 items addressing seven subscales: sleep duration, efficiency, quality, latency, medication use, disturbances and daytime dysfunctions.
Basic symptoms indicative of RED-S will be assessed by 17 questions about meal pattern, menstrual function and injuries. These questions were developed and previously used with a Swedish figure skating population, 13 years and older (n=224; Edlund, 2020).
Dual-Energy X-ray Absorptiometry (DEXA) will be carried out on both athletes and controls, comparing bone mineral density between the groups at baseline.
Data analysis and statistics:
Group comparisons between climbers and controls examining the difference between the above-mentioned variables between the study groups. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Group comparisons examining gender differences among climbers regarding the above-mentioned variables. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Group comparisons examining differences among climbers of different level (Elite and advanced) regarding the above-mentioned variables. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Associations in climbers between ED symptoms with regards to bone health as measured by Dual-Energy X-ray Absorptiometry (DXA).
- Conditions
- Mental Health Issue, Musculoskeletal Pain, Eating Disorders, Relative Energy Deficiency in Sport
- Being tested
- Web based surveys, DXA
- Keywords
- Depression, Anxiety, Stress, Pain, Rock climbing, Eating disorders, Cohort
- Medical subject headings
- Musculoskeletal Pain, Feeding and Eating Disorders, Relative Energy Deficiency in Sport, Depression, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based surveysOther
A web-based survey will explain the purpose, aims, and ethical rights, as well as how to complete the questionnaire online. Further, information about, and an invitation to participate in the DXA-scan will be included with this information. Upon electronic consent by both parent and athlete (or just athlete if of consenting age (15 y o a)), access to the multi-section questionnaire will be granted. Contact details of the researchers will be available in case of difficulties comprehending the questions. Following completion, the participants' data will be sent to a secure database for analysis. Participants will be ensured of the confidentiality of the study and will be free to withdraw from the study. Parents will also be asked to provide their consent if participants age is under 14.
DXARadiation
All participants will be invited to complete a DXA scan at baseline. DXA is to date the most reliable way of examining the long-term physical consequences of RED-S.
| Study group | Role | What they receive |
|---|---|---|
| Rock Climbers | The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older. There are approximately 40 climbers eligible at elite level and a minimum of 80 climbers at sub-elite level of competition. Receives: Other: Web based surveys; Radiation: DXA | |
| Controls | A non-athlete control group (n matched to the study group) from the general population, will be invited to participate in the study. Receives: Other: Web based surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating disorders
Eating Disorders: The Eating Disorders Examination-Questionnaire (EDE-Q 6.0) will be used and consists of four subscales: restraint, eating concern, shape concern and weight concern, addressing core dimensions of eating disorders (Berg et al., 2012). Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 2 on the global scale indicate a sublclinical eating disorder and a score of 4 or higher on the global score is generally used as clinically significant.
Measured: 2022-2025
Relative energy deficiency
Basic symptoms indicative of RED-S will be assessed by 17 questions about meal pattern, menstrual function and injuries. These questions were developed and previously used with a Swedish figure skating population, 13 years and older (n=224; Edlund, 2020).
Measured: 2022-2025
Secondary outcomes (6)
Sleep quality
The Pittsburg Sleep Quality Index (PSQI; Carpenter \& Andrykowski,1998) will be used and includes 19 items addressing seven subscales: sleep duration, efficiency, quality, latency, medication use, disturbances and daytime dysfunctions. In scoring the PSQI, the seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 2022-2025
Depression, anxiety and stress
Symptoms of mental health problems are measured by the Depression Anxiety Stress Scale (DASS-21; Lovibond \& Lovibond, 1995).
The outcome is nominal with categories according to the following:
Depression:
Normal 0-9 Mild 10-12 Moderate 13-20 Severe 21-27 Extremely severe 28-42.
Anxiety:
Normal 0-6 Mild 7-9 Moderate 10-14 Severe 15-19 Extremely severe 20-42.
Stress:
Normal 0-9 Mild 10-12 Moderate 13-20 Severe 21-27.
Measured: 2022-2025
Body Image
The brief version of the 8 item Body Shape Questionnaire, (BSQ-8C; Welch, Lagerström \& Ghaderi, 2012) will be used. The outcome is nominal with categories according to the following:
No concern with shape <19. Mild concern with shape 19-25. Moderate concern with shape 26-33. Marked concerns with shape >33)
Measured: 2022-2025
Compulsive Exercise
Weight loss behaviors and emotion regulation using training is measured with Compulsive Exercise Test (CET; Taranis, Touyz \& Meyer, 2011). The subscales included are: "Weight control exercise" (WCE) and "Avoidance of negative affect and rule driven behavior" (ANARDB). The CET is a self-reported questionnaire designed to explore the emotional, cognitive and behavioral characteristics of compulsive exercise. It comprises 24 items answered on a 6-point Likert scale, from 0 (never true) to 5 (always true). CET consists of five subscales: "avoidance and rule-driven behavior," "weight control exercise," "mood improvement," "lack of exercise enjoyment," and "exercise rigidity." Mean scores of each subscale are measured.
Measured: 2022-2025
Perfectionism
The Frost Multidimensional Perfectionism Scale (FMPS; Frost, Marten, Lahart \& Rosenblate, 1990) will be used, utilizing the subscales of personal standards (PS) and concern over mistakes (CM). The outcome is dichotomous with a cut off score of >29.
Measured: 2022-2025
Overuse injuries
The Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O; Clarsen et al., 2020) will be used and measures athlete's self-reported a) participation in sport, b) modified training/competing,c) performance and d) pain in a 4-grades scale from full participation to could not participate due to problems (of injury).
Measured: 2022-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start15 Feb 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sophiahemmet University
- Responsible party
- Sponsor
- Investigators
- Mikael Sansone, M.D, Ph.D., Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587270
- Sponsor's protocol ID
- CLIMB
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Parallel studies are in planning with Universities of Norway for cross-cultural comparisons with merged data sets.
Publications
Nigicser I, Identeg F, Sansone M, Hedelin H, Forsberg N, Tranaeus U, Edlund K. Do Swedish rock-climbers exhibit more eating disorder and body dissatisfaction symptoms than non-climbers? A cross-sectional study. BMJ Open. 2024 Oct 16;14(10):e085265. doi: 10.1136/bmjopen-2024-085265.
PubMed 39414282Edlund K, Nigicser I, Sansone M, Identeg F, Hedelin H, Forsberg N, Tranaeus U. Protocol for a 2-year longitudinal study of eating disturbances, mental health problems and overuse injuries in rock climbers (CLIMB). BMJ Open. 2023 Sep 13;13(9):e074631. doi: 10.1136/bmjopen-2023-074631.
PubMed 37709336
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLIMB: Climbers' Longitudinal Attitudes to Injuries, Mental Health and Body Image
- ClinicalTrials.gov ID
- NCT05587270
- Acronym / sponsor ID
- CLIMB
- Conditions
- Mental Health Issue, Musculoskeletal Pain, Eating Disorders, Relative Energy Deficiency in Sport
- Keywords
- Depression, Anxiety, Stress, Pain, Rock climbing, Eating disorders, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sophiahemmet University
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eating disorders (ED) are serious mental illnesses with high mortality rates and significant impact on an individual's quality of life. These disorders are characterized by preoccupation of weight and shape, leading to restrictive eating behavior and compensatory behaviors (purging and excessive/compulsive exercise). Comorbidities with mental health problems are common. Athletes in leanness-focused sports report higher levels of EDs compared to athletes from sports without such focus . Energy Availability (EA) has been suggested the key variable in "Relative Energy Deficiency in Sports" (RED-S) with studies reporting impairment of reproductive function and bone formation.
Climbing is a weight sensitive sport where athletes generally, benefit from a lean body shape and low weight, a risk factors for ED. Therefore, climbing athletes can be expected to be at high-risk to develop these conditions. To our knowledge, there are no studies on the prevalence and magnitude of EDs among climbers. Due to the overrepresentation of EDs reported in sports and the poor treatment prognosis, early detection and prevention of ED symptoms are essential. The present study will study the prevalence of ED symptoms, changes over time and trajectories of key variables along with related problem areas such as bone health and mental health problems in order to take steps towards tailored strategies for the prevention of EDs in climbing.
The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite vs. sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables over time will be analyzed.
Detailed description
Study objectives:
The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite and sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables (with the exception of bone health) over time will be analyzed.
Specific research questions:
- BASELINE
To determine the prevalence of disordered eating behaviors, mental health problems, compulsive training, self-reported symptoms of LEA, overuse injuries and bone density in advanced to elite climbers compared to controls.
Are there gender differences among climbing athletes as far as ED symptoms, body image, compulsive training, perfectionism, mental health problems, sleep quality and overuse injuries?
Do climbing athletes at higher levels of competition (elite vs. advanced) report differing levels of symptoms related to disordered eating behaviors, mental health problems, compulsive training, self- reported symptoms of LEA, overuse injuries and bone density than normal controls?
Are there difference between climbing athletes reporting differences in ED symptoms respectively with regards to bone health as measured by Dual-Energy X-ray Absorptiometry (DXA).
- FOLLOW UP
To study the trajectories of mentioned variables over time and examine the association between modifiable risk factors and ill health and outcome measured by DASS21, EDEQ and OSLO SPORTS OVERUSE INJURIES QUESTIONNAIRE.
Study design:
The study design is longitudinal using a web-based questionnaire with four measures over a two-year period (baseline, 6-, 12- and 24 months) and additional follow-ups at 3 and 5 years after baseline. The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older. There is a minimum of 40 climbers eligible at elite level and a minimum of 80 climbers at sub-elite level of competition. A non-elite athlete control group (n matched of the climbing group) from the general population, will be invited to participate in the study.
In addition to the web-based questionnaire, participants will be invited to the measurement of bone health using DXA at the baseline measurement.
Source population:
The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older.
Sample size: To our knowledge, no previous research has been presented and since the climbing population is small, and the expected outcome measures (ED-symptoms, mental health problems, injuries and bone health) are unknown, we will not be able to carry out power calculations. However, based on similar injury research by one of the co-applicants, a power calculation was estimated on standard deviation of 1.0, significant level set to 0.05, and statistical power 0.80. The study needed 38 participants in each group to detect estimated group differences. We will therefore include at least 40 in each group.
Data collection
The study has been endorsed by the Swedish Climbing Federation. Study information will be distributed via the federation to national teams and clubs asking them to distribute the web-based survey link (computed by the research team) to the climbing athletes and controls. The web-based survey will explain the purpose, aims, and ethical rights, as well as how to complete the questionnaire. Further, information regarding, and an invitation to participate the DXA-scan will be included with this information. Upon electronic consent by both parent and athlete (or just athlete if of consenting age (15 y o a)), access to the multi-section questionnaire will be granted. Contact details of the researchers will be available in case of difficulties comprehending the questions. Following completion, the participants' data will be stored at a secure database for analysis. Participants will be ensured of the confidentiality of the study and will be free to withdraw from the study at any time. Appointments for DXA-scans will be set up after informed consent has been established for the study as a whole.
Exposures
Rock-climbing
Outcomes
Eating Disorders: The Eating Disorders Questionnaire (EDE-Q 6.0) will be used and consists of four subscales: restraint, eating concern, shape concern and weight concern, addressing core dimensions of eating disorders (Berg et al., 2012).
Overuse injuries: The Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O; Clarsen et al., 2020) will be used and measures athlete's self-reported a) participation in sport, b) modified training/competing,c) performance and d) pain in a 4-grades scale from full participation to could not participate due to problems (of injury).
Perfectionism: The Frost Multidimensional Perfectionism Scale (FMPS; Frost, Marten, Lahart \& Rosenblate, 1990) will be used, utilizing the subscales of personal standards (PS) and concern over mistakes (CM).
Compulsive Exercise: Weight loss behaviors and emotion regulation using training is measured with Compulsive Exercise Test (CET; Taranis, Touyz \& Meyer, 2011). The subscales included are: "Weight control exercise" (WCE) and "Avoidance of negative affect and rule driven behavior" (ANARDB).
Body Image: The brief version of the 8 item Body Shape Questionnaire, (BSQ-8C; Welch, Lagerström \& Ghaderi, 2012) will be used.
Symptoms of mental health problems are measured by the Depression Anxiety Stress Scale (DASS-21; Lovibond \& Lovibond, 1995).
Sleep quality: The Pittsburg Sleep Quality Index (PSQI; Carpenter \& Andrykowski,1998) will be used and includes 19 items addressing seven subscales: sleep duration, efficiency, quality, latency, medication use, disturbances and daytime dysfunctions.
Basic symptoms indicative of RED-S will be assessed by 17 questions about meal pattern, menstrual function and injuries. These questions were developed and previously used with a Swedish figure skating population, 13 years and older (n=224; Edlund, 2020).
Dual-Energy X-ray Absorptiometry (DEXA) will be carried out on both athletes and controls, comparing bone mineral density between the groups at baseline.
Data analysis and statistics:
Group comparisons between climbers and controls examining the difference between the above-mentioned variables between the study groups. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Group comparisons examining gender differences among climbers regarding the above-mentioned variables. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Group comparisons examining differences among climbers of different level (Elite and advanced) regarding the above-mentioned variables. Specific tests will be depending on the type of data, distribution of the variables and the size of the study population.
Associations in climbers between ED symptoms with regards to bone health as measured by Dual-Energy X-ray Absorptiometry (DXA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rock Climbers | – | Other: Web based surveys, Radiation: DXAThe whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older. There are approximately 40 climbers eligible at elite level and a minimum of 80 climbers at sub-elite level of competition. |
| Controls | – | Other: Web based surveysA non-athlete control group (n matched to the study group) from the general population, will be invited to participate in the study. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The whole eligible population of Swedish climbers on elite- or sub-elite levels of competition will be invited to participate in the study. Participants will be both male and female, 13 years and older.
Key inclusion criteria (4 listed)
- Age over 13
- Men: completed a boulder route rated harder than 6b or a lead route rated 7a+ within the last three months.
- Women: completed a boulder route rated harder than 6a or a lead route rated 6c within the last year.
Key exclusion criteria (2 listed)
- None
- Previous or current participation on elite level in any sport.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web based surveysA web-based survey will explain the purpose, aims, and ethical rights, as well as how to complete the questionnaire online. Further, information about, and an invitation to participate in the DXA-scan will be included with this information. Upon electronic consent by both parent and athlete (or just athlete if of consenting age (15 y o a)), access to the multi-section questionnaire will be granted. Contact details of the researchers will be available in case of difficulties comprehending the questions. Following completion, the participants' data will be sent to a secure database for analysis. Participants will be ensured of the confidentiality of the study and will be free to withdraw from the study. Parents will also be asked to provide their consent if participants age is under 14. | Other | Controls, Rock Climbers |
| DXAAll participants will be invited to complete a DXA scan at baseline. DXA is to date the most reliable way of examining the long-term physical consequences of RED-S. | Radiation | Rock Climbers |
Primary outcome
Eating disorders
Time frame: 2022-2025
Eating Disorders: The Eating Disorders Examination-Questionnaire (EDE-Q 6.0) will be used and consists of four subscales: restraint, eating concern, shape concern and weight concern, addressing core dimensions of eating disorders (Berg et al., 2012). Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 2 on the global scale indicate a sublclinical eating disorder and a score of 4 or higher on the global score is generally used as clinically significant.
Relative energy deficiency
Time frame: 2022-2025
Basic symptoms indicative of RED-S will be assessed by 17 questions about meal pattern, menstrual function and injuries. These questions were developed and previously used with a Swedish figure skating population, 13 years and older (n=224; Edlund, 2020).
6 secondary outcomes
Sleep quality
Time frame: 2022-2025
Depression, anxiety and stress
Time frame: 2022-2025
Body Image
Time frame: 2022-2025
Compulsive Exercise
Time frame: 2022-2025
Perfectionism
Time frame: 2022-2025
Overuse injuries
Time frame: 2022-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 39414282Nigicser I, Identeg F, Sansone M, Hedelin H, Forsberg N, Tranaeus U, Edlund K. Do Swedish rock-climbers exhibit more eating disorder and body dissatisfaction symptoms than non-climbers? A cross-sectional study. BMJ Open. 2024 Oct 16;14(10):e085265. doi: 10.1136/bmjopen-2024-085265.
- Derived from this study: PubMed 37709336Edlund K, Nigicser I, Sansone M, Identeg F, Hedelin H, Forsberg N, Tranaeus U. Protocol for a 2-year longitudinal study of eating disturbances, mental health problems and overuse injuries in rock climbers (CLIMB). BMJ Open. 2023 Sep 13;13(9):e074631. doi: 10.1136/bmjopen-2023-074631.
- Individual participant dataSharing planned: Undecided. Parallel studies are in planning with Universities of Norway for cross-cultural comparisons with merged data sets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Sansone, M.D, Ph.D. principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Musculoskeletal Pain, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Sansone, M.D, Ph.D. (+46709474257, mikael.sansone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorders (time frame: 2022-2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.