NCT07464899

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Feb 2024Apr 2030

Study Start

First participant enrolled

February 1, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Expected
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

22 days

First QC Date

August 5, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

sport nutritionquestionnariesathletesdietary-nutritional assessmentbody compositiondisability

Outcome Measures

Primary Outcomes (4)

  • Body Mass

    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)

    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

    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

    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 Outcomes (3)

  • Dietary intake assessed using the Food4Me FFQ

    4 years

  • Supplement consumption assessed using the Sports Supplement Intake Questionnaire

    4 years

  • Physical Activity Level assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)

    4 years

Study Arms (2)

Male

adult male athletes with disabilities

Other: DietOther: body compositionOther: Physical activityOther: health status

Female

adult female athletes with disabilities

Other: DietOther: body compositionOther: Physical activityOther: health status

Interventions

DietOTHER

frequency of food and supplement consumption

FemaleMale

body composition assessment

FemaleMale

Physical activity level

FemaleMale

perception of health status

FemaleMale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Athletes with disabilities from the different sports disciplines that belong to 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).

You may qualify if:

  • 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.

You may not qualify if:

  • No attendance to the evaluations
  • Reporting less than 80% of assistance to physical activity sessions reported by trainer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Alicante

San Vicent del Raspeig, Alicante, 03690, Spain

RECRUITING

Related Publications (6)

  • Flueck JL. Body Composition in Swiss Elite Wheelchair Athletes. Front Nutr. 2020 Jan 22;7:1. doi: 10.3389/fnut.2020.00001. eCollection 2020.

    PMID: 32039228BACKGROUND
  • 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.

    PMID: 32402793BACKGROUND
  • 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.

    PMID: 19997027BACKGROUND
  • 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.

    PMID: 29207495BACKGROUND
  • 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.

    PMID: 39641837BACKGROUND
  • 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.

    PMID: 27270749BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Interventions

DietBody CompositionExerciseHealth Status

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaBiochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Jose Miguel Martinez Sanz, Dr

CONTACT

David Romero García, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor. Director of the Research Group on Applied Dietetics, Nutrition and Body Composition. Nursing Department. Faculty of Health Sciences. University of Alicante

Study Record Dates

First Submitted

August 5, 2025

First Posted

March 11, 2026

Study Start

February 1, 2024

Primary Completion

February 23, 2024

Study Completion (Estimated)

April 30, 2030

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).

Locations