- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464899
Body Composition and Lifestyles in Athletes With Disabilities (PADES)
Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes With Disabilities (PADES)
Disability involves limitations that affect mobility and the ability to perform daily activities and achieve competitive goals. It is expected that disability has a significant impact on body composition, including reductions in lean mass and bone mineral content, and increases in fat mass and its distribution. Additionally, the assessment of food and dietary supplement intake among athletes with disabilities remains poorly described, despite its relevance in both sports and health contexts due to the potential benefits of individualized nutritional strategies.
This research project, entitled Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes with Disabilities (PADES), aims to describe the anthropometric characteristics, physical exercise practices, and food and supplement intake in Spanish athletes with disabilities. The study seeks to address the current lack of standardized anthropometric data and the limited information on dietary and supplementation patterns in this population, which hinders a comprehensive understanding of the physiological, nutritional, and biomechanical aspects essential for their health and athletic performance. A cross-sectional, descriptive-correlational study will be conducted in Spanish athletes with disabilities recruited through the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).
Study Overview
Status
Intervention / Treatment
Detailed Description
The field of disability, there is a notable lack of standardized data on anthropometric measurements, physical activity practices, and food and/or supplement intake among athletes with disabilities. This gap limits our understanding of key physiological, nutritional, and biomechanical aspects of this population, making it difficult to generate evidence-based knowledge applicable to their health, athletic performance, and overall well-being. In the absence of specific data, designing personalized and effective nutrition or training programs becomes more challenging and imprecise.
The diversity in types of disabilities, functional classifications, and levels of physical activity demands an evidence-based approach to ensure that interventions are safe, effective, and tailored to the individual needs of athletes. Anthropometric assessment, dietary and supplement intake evaluation, as well as physical activity practices are measurable factors related to the nutritional health status of athletes with disabilities, directly influencing their physical performance and contributing to safer and more effective sports participation.
Establishing reference tables or consumption patterns will allow for comparisons between different types of disabilities and/or functional classes. These comparisons are essential to identify trends and develop targeted intervention strategies that benefit the broader population of athletes with disabilities.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jose Miguel Martinez Sanz, Dr
- Phone Number: +34 620420726
- Email: josemiguel.ms@ua.es
Study Contact Backup
- Name: David Romero García, Dr
- Email: david.romero@ua.es
Study Locations
-
-
Alicante
-
San Vicent del Raspeig, Alicante, Spain, 03690
- Recruiting
- Faculty of Health Sciences. University of Alicante
-
Contact:
- Manuel Fernández Alcántara, Dr
- Phone Number: Ext. 2236 +34965903400
- Email: mfernandeza@ua.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acceptation of informed consent
- Have a federation license and at least two years of experience practicing the sport in which they will be classified.
- Follow a training program with a minimum frequency of three days per week.
- Have maintained training continuity for at least one month without absences.
- Any type of disability.
Exclusion Criteria:
- No attendance to the evaluations
- Reporting less than 80% of assistance to physical activity sessions reported by trainer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Male
adult male athletes with disabilities
|
Physical activity level
body composition assessment
perception of health status
frequency of food and supplement consumption
|
|
Female
adult female athletes with disabilities
|
Physical activity level
body composition assessment
perception of health status
frequency of food and supplement consumption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass
Time Frame: 4 years
|
Measure: body mass. Unit of Measure: kilograms (kg). Description: measured using a SECA 862 scale or SECA 676 wheelchair scale according to the ISAK protocol. |
4 years
|
|
Linear Dimensions (Stature, Girths, Lengths and Breadths)
Time Frame: 4 years
|
Measures: stretch stature, sitting height, arm span, girths, lengths and breadths. Unit of Measure: centimeters (cm). Description: stretch stature and sitting height will be measured using a SECA 217 stadiometer; arm span will be measured using a Smartmet arm-span device; girths will be measured using an inextensible Smartmet metal tape; breadths will be measured using a Holtain small sliding caliper and a Realmet large sliding caliper; and lengths will be determined using a Smartmet segmometer according to the ISAK protocol. |
4 years
|
|
Skinfolds
Time Frame: 4 years
|
Measure: skinfolds (triceps, subscapular, biceps, iliac crest, supraspinale, abdominal, thigh and calf). Unit of Measure: millimeters (mm). Description: measured with a Holtain skinfold caliper following the ISAK protocol. |
4 years
|
|
Body Composition Variables
Time Frame: 4 years
|
Measures: fat mass, fat-free mass, adipose mass, muscle mass, and bone mass. Unit of Measure: kilograms (kg). Description: fat mass will be estimated using the Katch-McArdle (1973) equation, based on body mass and selected skinfolds; fat-free mass will be estimated as the difference between body mass and fat mass; adipose mass will be estimated using the Kerr (1991) equation, based on stretch stature and selected skinfolds; muscle mass will be estimated using the Lee (2000) equation, based on stretch stature and corrected girths; and bone mass will be estimated using the Rocha (1974) equation, based on stretch stature and selected breadths. |
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intake assessed using the Food4Me FFQ
Time Frame: 4 years
|
A questionnaire validated in terms of content, applicability, structure, and presentation by University College Dublin and Crème Software Ltd. will be used (Food4Me FFQ).
It is a self-administered, online, semi-quantitative food frequency questionnaire.
It comprises a total of 24 questions divided into two main sections.
The first section collects the participant's age, the team they play for (which identifies the participant's sex), and playing position.
The second section includes 21 questions assessing the intake of various food and beverage groups over the previous month (average intake of 157 foods).
Consumption frequency is assessed by selecting one of the following options: never or less than once per month; 1-3 times per month; once per week; 2-4 times per week; 5-6 times per week; once per day; 2-3 times per day; 5-6 times per day; and >6 times per day.
|
4 years
|
|
Supplement consumption assessed using the Sports Supplement Intake Questionnaire
Time Frame: 4 years
|
A questionnaire validated using qualitative methodology and self-administered either in person or online will be used.
The questionnaire comprises a total of 34 questions divided into three main sections.
The first section, comprising 6 questions, collects anthropometric data such as age, body mass, and height; personal data such as sex and date of birth; and sociodemographic information such as the autonomous community of residence.
The second section includes 10 questions covering sport participation and its context, including the team/sports club, competition level, years of practice, and training and competition schedules.
The final section, consisting of 14 questions, focuses on sports supplement consumption, namely which sports supplements participants consume, why they consume them, who advises them to consume them, where they purchase them, when they take them, and their perceived effects after consumption.
|
4 years
|
|
Physical Activity Level assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Time Frame: 4 years
|
The IPAQ-SF comprises 9 items and records the activity of four intensity levels: vigorous-intensity acitivity, moderate-intensity acitivity, walking and sitting.
This version does not allow for a detailed assessment of physical activity across each domain of daily life; however, it integrates aspects of all domains, enabling the recording of total time and energy expenditure.
Both versions assess three specific characteristics of activity: intensity (light, moderate, or vigorous), frequency (measured in days per week), and duration (time per day).
|
4 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lachat C, Hawwash D, Ocke MC, Berg C, Forsum E, Hornell A, Larsson C, Sonestedt E, Wirfalt E, Akesson A, Kolsteren P, Byrnes G, De Keyzer W, Van Camp J, Cade JE, Slimani N, Cevallos M, Egger M, Huybrechts I. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement. PLoS Med. 2016 Jun 7;13(6):e1002036. doi: 10.1371/journal.pmed.1002036. eCollection 2016 Jun.
- Serafini S, Charrier D, Izzicupo P, Esparza-Ros F, Vaquero-Cristobal R, Petri C, Mecherques-Carini M, Baglietto N, Holway F, Tinsley G, Paoli A, Campa F. Anthropometric-based predictive equations developed with multi-component models for estimating body composition in athletes. Eur J Appl Physiol. 2025 Mar;125(3):595-610. doi: 10.1007/s00421-024-05672-3. Epub 2024 Dec 6.
- Capling L, Beck KL, Gifford JA, Slater G, Flood VM, O'Connor H. Validity of Dietary Assessment in Athletes: A Systematic Review. Nutrients. 2017 Dec 2;9(12):1313. doi: 10.3390/nu9121313.
- Flueck JL. Body Composition in Swiss Elite Wheelchair Athletes. Front Nutr. 2020 Jan 22;7:1. doi: 10.3389/fnut.2020.00001. eCollection 2020.
- Cavedon V, Zancanaro C, Milanese C. Body composition assessment in athletes with physical impairment who have been practicing a wheelchair sport regularly and for a prolonged period. Disabil Health J. 2020 Oct;13(4):100933. doi: 10.1016/j.dhjo.2020.100933. Epub 2020 Apr 22.
- Bernardi M, Guerra E, Di Giacinto B, Di Cesare A, Castellano V, Bhambhani Y. Field evaluation of paralympic athletes in selected sports: implications for training. Med Sci Sports Exerc. 2010 Jun;42(6):1200-8. doi: 10.1249/MSS.0b013e3181c67d82.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Behavior, Animal
- Feeding Behavior
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Public Health
- Environment and Public Health
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Population Characteristics
- Demography
- Epidemiologic Measurements
- Biochemical Phenomena
- Chemical Phenomena
- Body Constitution
- Metabolism
- Exercise
- Diet
- Health Status
- Body Composition
Other Study ID Numbers
- UA-2025-02-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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