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Pronti A Salpare: Studio di fattibilità Sull'Impatto Della Vela Come Ergoterapia in Pazienti Con Malattie Rare Scheletriche - Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy for Rare Skeletal Diseases
Sponsor study identifier
interventional
8
1 country
1
Study Start
May 16, 2024
Actual (reported)Primary Completion
September 13, 2024
Actual (reported)Study Completion
September 13, 2024
Actual (reported)Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options. Adventure Therapy, employing exposure to natural environments, has shown promise in improving self-esteem, autonomy, and social skills in chronic illness and disability populations. This pilot study explores the feasibility and preliminary efficacy of a sailing-based intervention for enhancing physical, social, and psychological well-being in this specific population. Outcome Measures The primary outcome is to investigates the feasibility of sailing to improve well-being and quality of life in patients living with rare skeletal disorders. Furthermore, the investigators hypothesize that participation in a sailing program led by occupational therapists will lead to improvements in:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2024
Actual (reported)May 2, 2024
Actual (reported)May 16, 2024
Actual (reported)September 13, 2024
Actual (reported)September 13, 2024
Actual (reported)March 21, 2025
Actual (reported)Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
T0: Baseline
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
5-day sailing activity
* Sailing activity (4 h/die) * Stretching exercises pre and post-sailing activity * Post-activity debriefing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Cornaglia Ferraris P. [Adventure therapy: principles, practice, perspectives.]. Recenti Prog Med. 2018 Oct;109(10):487-493. doi: 10.1701/3010.30086. Italian.
MacLachlan M. Sailing as an Intervention. In: MacLachlan M, editor. Maritime Psychology: Research in Organizational & Health Behavior at Sea. Cham: Springer International Publishing; 2017. https://doi.org/10.1007/978-3-319-45430-6_10
Thompson T, Lamont-Robinson C, Williams V. At sea with disability! Transformative learning in medical undergraduates voyaging with disabled sailors. Med Educ. 2016 Aug;50(8):866-79. doi: 10.1111/medu.13087.
Luca Sangiorgi, MD, PhD
IRCCS Istituto Ortopedico Rizzoli
8 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2024
First Posted
May 2, 2024
Study Start
May 16, 2024
Actual (reported)T1: up to 2 weeks
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
T2: up to 3 weeks
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
T3: up to 3 months
Self-esteem
T0: Baseline
Self-esteem
T1: up to 2 weeks
Self-esteem
T2: up to 3 weeks
Self-esteem
T3: up to 3 months
Motor Coordination
T0: Baseline
Information on the Functioning and Disability of an Individual
T0
Information on the Functioning and Disability of an Individual
T3
Kinesiophobia
T1
Contact the study team to confirm eligibility.
Recio AC, Becker D, Morgan M, Saunders NR, Schramm LP, McDonald JW 3rd. Use of a virtual reality physical ride-on sailing simulator as a rehabilitation tool for recreational sports and community reintegration: a pilot study. Am J Phys Med Rehabil. 2013 Dec;92(12):1104-9. doi: 10.1097/PHM.0000000000000012.
Tracey D, Gray T, Truong S, Ward K. Combining Acceptance and Commitment Therapy With Adventure Therapy to Promote Psychological Wellbeing for Children At-Risk. Front Psychol. 2018 Aug 27;9:1565. doi: 10.3389/fpsyg.2018.01565. eCollection 2018.
Capurso, M.; Borsci, S. Effects of a Tall Ship Sail Training Experience on Adolescents' Self-Concept. International Journal of Educational Research 2013, 58, 15-24. https://doi.org/10.1016/j.ijer.2013.01.004.
Gill E, Goldenberg M, Starnes H, Phelan S. Outdoor adventure therapy to increase physical activity in young adult cancer survivors. J Psychosoc Oncol. 2016 May-Jun;34(3):184-99. doi: 10.1080/07347332.2016.1157718. Epub 2016 Mar 3.
Zebrack B, Kwak M, Sundstrom L. First Descents, an adventure program for young adults with cancer: who benefits? Support Care Cancer. 2017 Dec;25(12):3665-3673. doi: 10.1007/s00520-017-3792-7. Epub 2017 Jun 27.
Aprile I, Iacovelli C, Iuvone L, Imbimbo I, Cruciani A, Pecchioli C, Manozzi FM, Padua L. Use of a Virtual-Technological Sailing Program to Prepare Children With Disabilities for a Real Sailing Course: Effects on Balance and Quality of Life. J Child Neurol. 2016 Jul;31(8):1074-80. doi: 10.1177/0883073816638756. Epub 2016 Mar 28.
Boarini M, Banchelli F, Fittipaldi S, Scognamiglio D, Farella GM, Platano D, Rogati G, Di Sipio E, Villa G, Berti L, Leardini A, Sartini S, Scopinaro A, Sangiorgi L. Feasibility and safety of sailing based rehabilitation for rare skeletal disorders using wearable sensors and patient reported outcomes. Sci Rep. 2025 Oct 23;15(1):37153. doi: 10.1038/s41598-025-22231-8.
Primary Completion
September 13, 2024
Actual (reported)Study Completion
September 13, 2024
Actual (reported)Last Updated
March 21, 2025
Results First Posted
March 21, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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