Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls

NCT04172142 | Unknown

• 1 other identifier: 2019-17/15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chest wall deformities are the development of ribs, cartilage and sternum that form the chest wall together with isolated or abnormalities of the musculoskeletal system. Pectus excavatum and carinatum deformities are most common. It is reported that individuals with this problem have posture and physical impairments, difficulty in psychosocial relations and decreased quality of life.Therefore, in this study, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Conditions

Pectus Deformity; Physical Disability; Psychosocial Impairment

Keywords

Pectus Carinatum; Pectus Excavatum; Physical Impairment; Psychosocial Impairment

Outcome Measures

Primary Outcomes (9)

• New York Posture Rating Chart

  The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments. 13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior). A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. higher the points better the postural alignment

  Baseline time

• International Physical Activity Questionnaire-Short Form (IPAQ) in the assessment of physical activity.

  The questionnaire interrogates the last 7 days regarding the following activities: (1) Time (minutes) spent for vigorous physical activities (football, basketball, aerobics, or fast bicycling, heavy lifting, carrying loads, etc.), (2) Time (minutes) spent for moderate physical activities (carrying light load, bicycling at a regular pace, folk dances, bowling, tennis etc.), and (3) Time spent for walking and time spent for sitting in a day. Physical activity levels of the participants were classified into low \[600 the metabolic equivalent of task (MET)-minute/week), moderate (600 to 3000 MET minute/week), and high (\> 3000 MET- minute/week) activity groups based on total physical activity scores. higher the points better the physical activity.

  Baseline time

• Extended version of the Musculoskeletal Questionnaire (NMQ-E)

  The extended version of the musculoskeletal questionnaire is completed by self-administration or face to face interview and provides reliable information on the onset, prevalence and outcomes of musculoskeletal pain in nine body regions (the neck, shoulder, upper back, elbow, wrist/hand, low back, hip/ thigh, knee, ankle/foot). The NMQ-E interrogates ache, pain or discomfort experienced in the nine body parts to date, for the last 12 months, for the last four weeks and on the day of the administration,with binary choice questions (yes or no).The frequency of the answer yes is high and shows us that musculoskeletal pain is high and is a bad score.

  Baseline time

• Flexibility test

  bilateral sit-and-reach test: Sitting on the floor or a mat, legs straight and feet 8-12 inches apart, the person being tested reaches forward with the arms (hands overlapping). The distance of reach is measured in inches using a measuring line marked on the floor

  Baseline time

• Grip strength

  The test is conducted with the participant seated on a chair (with a back and no arm rests), with the lower limbs resting on the ground. The shoulder of the limb to be tested remained adducted and neutral for rotation, with the elbow flexed at 90 °, the forearm neutral and wrist extension between 0 and 30 ° with 0-15 degrees of ulnar deviation. During the test, constant verbal encouragement was given to the participants to use their maximum strength. The test is repeated three times to obtain the mean.

  Baseline time

• Abdominal muscle endurance

  Abdominal muscle endurance is measured as the number of correctly completed sit-ups in 30seconds. Sit-ups were performed with the hands placed at the side of the head, knees bent at 90°, and the feet secured by the investigator. A full sit-up is defined as touching the knees with the elbows and returning the shoulders to the ground. A higher number of completed sit-ups indicates greater abdominal muscle endurance.

  Baseline time

• Back strength

  Back strength of the participants is measured using a Back-leg-chest dynamometer. The participant was positioned with body erect and knees bent so that the grasping hand rests at proper height. Then, by straightening the knees and lifting the chain of the dynamometer, pulling force is applied on the handle. The body would be inclined forward at an angle of 60 degrees for the measurement of back strength

  Baseline time

• Social Appearance Anxiety Scale

  The scale a 16-item measure, was developed to assess the respondent's anxiety surrounding situations in which one's appearance may be evaluated. Response options for each item range from 1 (not at all) to 5 (extremely). The total score is calculated by summing across all items, after reverse coding the first item. Scores range from 16 to 80, with higher scores indicating greater fear

  Baseline time

• Pediatric Quality of Life Inventory (PedsQL),

  QoL was measured with one of the three age-appropriate versions (5-7, 8-12, 13-18 years). This scale measures children's perceptions and reflects their concerns on the dimensions of physical health (8 items) and psychosocial health, the latter comprising the subdimensions of emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). The overall QoL score is obtained by adding up the scores for all dimensions. Children were asked to indicate on a 3-point (5-7 year version) or 5-point (8 years and older versions) Likert scale to what extent they had experienced difficulties regarding these dimensions over the last month (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). The answers were reverse-scored and rescaled to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A score of 100 represents the best possible QoL, a score of 0 the worst.

  Baseline time

Secondary Outcomes (2)

• Brief Symptom Inventory

  Baseline time

• Body Image Scale (BIS)

  Baseline time

Study Arms (3)

Control group

Healthy individuals of similar age and sex who meet the inclusion criteria

Pectus Excavatum

Individuals with pectus excavatum that meet the inclusion criteria

Pectus Carinatum

Individuals with pectus excavatum that meet the inclusion criteria

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pectus Excavatum,Pectus Carinatum and Healthy Controls (10-18 years age)

You may qualify if:

• Diagnosis of chest wall deformity by doctor
• Not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals

You may not qualify if:

• Having chronic systemic disease
• Genetic disease
• Being psychologically diagnosed
• Having additional musculoskeletal diseases

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (15)

• Akkas Y, Gulay Peri N, Kocer B, Gulbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180.

  PMID: 30541247 BACKGROUND

• Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5.

  PMID: 25883894 BACKGROUND

• Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. doi: 10.1089/lap.2006.16.164.

  PMID: 16646710 BACKGROUND

• Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014.

  PMID: 18996250 BACKGROUND

• Blanco FC, Elliott ST, Sandler AD. Management of congenital chest wall deformities. Semin Plast Surg. 2011 Feb;25(1):107-16. doi: 10.1055/s-0031-1275177.

  PMID: 22294949 BACKGROUND

• Hart TA, Flora DB, Palyo SA, Fresco DM, Holle C, Heimberg RG. Development and examination of the social appearance anxiety scale. Assessment. 2008 Mar;15(1):48-59. doi: 10.1177/1073191107306673.

  PMID: 18258731 BACKGROUND

• Sahin NH, Durak Batigun A, Ugurtas S. [The validity, reliability and factor structure of the Brief Symptom Inventory (BSI)]. Turk Psikiyatri Derg. 2002 Summer;13(2):125-35. Turkish.

  PMID: 12794665 BACKGROUND

• Einsiedel E, Clausner A. Funnel chest. Psychological and psychosomatic aspects in children, youngsters, and young adults. J Cardiovasc Surg (Torino). 1999 Oct;40(5):733-6.

  PMID: 10597013 BACKGROUND

• Harkonen R, Piirtomaa M, Alaranta H. Grip strength and hand position of the dynamometer in 204 Finnish adults. J Hand Surg Br. 1993 Feb;18(1):129-32. doi: 10.1016/0266-7681(93)90212-x.

  PMID: 8436850 BACKGROUND

• Lockie R, Schultz A, Callaghan S, Jordan C, Luczo T, Jeffriess M. A preliminary investigation into the relationship between functional movement screen scores and athletic physical performance in female team sport athletes. Biol Sport. 2015 Mar;32(1):41-51. doi: 10.5604/20831862.1127281. Epub 2014 Nov 3.

  PMID: 25729149 BACKGROUND

• Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.

  PMID: 19047237 BACKGROUND

• Roberts J, Hayashi A, Anderson JO, Martin JM, Maxwell LL. Quality of life of patients who have undergone the Nuss procedure for pectus excavatum: Preliminary findings. J Pediatr Surg. 2003 May;38(5):779-83. doi: 10.1016/jpsu.2003.50166.

  PMID: 12720193 BACKGROUND

• Steinmann C, Krille S, Mueller A, Weber P, Reingruber B, Martin A. Pectus excavatum and pectus carinatum patients suffer from lower quality of life and impaired body image: a control group comparison of psychological characteristics prior to surgical correction. Eur J Cardiothorac Surg. 2011 Nov;40(5):1138-45. doi: 10.1016/j.ejcts.2011.02.019. Epub 2011 Mar 25.

  PMID: 21440452 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• WELCH KJ. Satisfactory surgical correction of pectus excavatum deformity in childhood; a limited opportunity. J Thorac Surg. 1958 Nov;36(5):697-713. No abstract available.

  PMID: 13588724 BACKGROUND

MeSH Terms

Conditions

Pectus Carinatum; Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nuray Alaca, PhD

CONTACT

+905324251290; nuray.alaca@acibadem.edu.tr

Mustafa Yüksel, Prof

CONTACT

+90216 566 57 79; drmustafayuksel@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 7, 2019
• Primary Completion: May 15, 2020
• Study Completion: August 15, 2020
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

TU (1)