The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis

NCT03336736 | Completed

• 1 other identifier: KingstonUSport
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This project focuses on the sub-group population with pulmonary sarcoidosis - a condition that causes red swollen tissue called granulomas to develop in organs such as the lungs. The condition is associated to symptoms of shortness of breath and a persistent dry cough. The aim of the research is to investigate the role of physical activity, exercise and diet within pulmonary sarcoidosis-related outcomes. Exercise has the potential to improve symptoms of pulmonary sarcoidosis including fatigue, dyspnoea, quality of life (QOL) and exercise tolerance. The use of exercise in symptomatic patients is supported by current evidence but is limited and requires further understanding, given the unique nature of the condition, in terms of physical and psychological outcomes. Specific dietary and exercise recommendations are limited by the lack of evidence for specific modifications such as the type(s), intensities, frequency and duration. The study will involve completion of validated questionnaires including quality of life (QOL; Sarcoidosis Health Questionnaire (SHQ) (see appendix III), the SHQ comprises of 29-item, 7 point Likert scale questionnaire and fatigue (Fatigue Assessment Scale; FAS (see appendix IV) and will require participants to attend two visits to the Kingston University, Human Performance Lab at Penrhyn Rd campus, this is to ensure reliability and validity for the data collected. The visits will consist of a range of physical tests including lung function, a six-minute walk test and muscle strength tests. The primary aim of the study is to ascertain the physical activity patterns in those with pulmonary sarcoidosis with regards to perceived physical activity, measured using the the International Physical Activity Questionnaires (IPAQ) (appendix V), which comprises of 27 items across five activity domains and actual physical activity ,measured by tri-axial accelerometry, fatigue assessment scale (appendix IV). The secondary aim of the study is to understand the effect of pulmonary sarcoidosis in relation to muscle strength and exercise capacity against physical activity, lung function and oxygen saturation and how these differ from healthy normative values. Participants will be asked to read the participant information and declare consent before starting the study. Only the researcher and supervisors of the study will have access to the raw data. Anonymity will be kept all times.

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary; ILD; Interstitial Lung Disease

Keywords

Physical Activity; Diet; Exercise; Sarcoidosis; Pulmonary sarcoidosis; Lung Function; Fitness; Strength; Endurance

Outcome Measures

Primary Outcomes (1)

• Daily physical activity measures against self-reported by tri-axial accelerometry

  minutes of physical activity per day

  7 days

Secondary Outcomes (13)

• Functional exercise capacity

  14 days

• Muscle strength (isokinetic dynamometer)

  14 days

• Lung function using spirometry

  14 days

• Quality of Life Score

  14 days

• Body Composition

  1 day

Study Arms (2)

Pulmonary Sarcoidosis

Self-reported and self-referred self-reported medically diagnosed pulmonary sarcoidosis. Exercise capacity and function will be assessed.

Diagnostic Test: Exercise

Control

Healthy age-matched control group with no known lung disease. Exercise capacity and function will be assessed.

Diagnostic Test: Exercise

Interventions

Exercise DIAGNOSTIC_TEST

The study design will be a prospective cross-sectional observational project, with no intervention. Data on a participant's physical activity levels, physical fitness and quality of life will be collected using physical testing and questionnaires.

Control; Pulmonary Sarcoidosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with known Pulmonary Sarcoidosis according to ATS/ERS/ WASOG criteria statement ascertained by self-reporting.

You may qualify if:

• Patients with known Sarcoidosis according to ATS/ERS/ WASOG criteria statement
• Written informed consent is obtained.
• Access to a computer with Internet

You may not qualify if:

• Contraindications to (not able to perform) physical tests or exercise testing - e.g. unstable cardiovascular disease, oncological, cardiac, neurological or orthopaedic history making them unable to participate screened by a sub-maximal fitness screening form (appendix ).
• An injury in the past 6 months that inhibits ability to perform exercise testing by a sub-maximal fitness screening form (appendix).
• Patients with a concurrent and predominant diagnosis of another significant respiratory disorder (for example: asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, or lung cancer) by a sub-maximal fitness screening form (appendix).
• Pregnancy
• Physical disability (non-ambulatory patient e.g. wheelchair or bed-bound)
• Inability to obtain informed consent
• Cognitive failure making them unable to give consent or understand questionnaires or instruction.

Sponsors & Collaborators

• Kingston University: lead

Study Sites (2)

Applied & Human Sciences Human Performance Lab

Kingston upon Thames, Surrey, KT1 2EE, United Kingdom

Location

Kingston University London

Kingston upon Thames, Surrey, KT1 2EE, United Kingdom

Location

Related Publications (11)

• Strookappe B, Saketkoo LA, Elfferich M, Holland A, De Vries J, Knevel T, Drent M. Physical activity and training in sarcoidosis: review and experience-based recommendations. Expert Rev Respir Med. 2016 Oct;10(10):1057-68. doi: 10.1080/17476348.2016.1227244. Epub 2016 Sep 8.

  PMID: 27552344 BACKGROUND

• Holland AE, Dowman LM, Hill CJ. Principles of rehabilitation and reactivation: interstitial lung disease, sarcoidosis and rheumatoid disease with respiratory involvement. Respiration. 2015;89(2):89-99. doi: 10.1159/000370126. Epub 2015 Jan 21.

  PMID: 25633076 BACKGROUND

• Judson MA, Chaudhry H, Louis A, Lee K, Yucel R. The effect of corticosteroids on quality of life in a sarcoidosis clinic: the results of a propensity analysis. Respir Med. 2015 Apr;109(4):526-31. doi: 10.1016/j.rmed.2015.01.019. Epub 2015 Feb 7.

  PMID: 25698652 BACKGROUND

• Alhamad EH, Shaik SA, Idrees MM, Alanezi MO, Isnani AC. Outcome measures of the 6 minute walk test: relationships with physiologic and computed tomography findings in patients with sarcoidosis. BMC Pulm Med. 2010 Aug 9;10:42. doi: 10.1186/1471-2466-10-42.

  PMID: 20696064 BACKGROUND

• Karadalli MN, Bosnak-Guclu M, Camcioglu B, Kokturk N, Turktas H. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial. Respir Care. 2016 Apr;61(4):483-94. doi: 10.4187/respcare.04312. Epub 2015 Dec 29.

  PMID: 26715771 BACKGROUND

• Huppmann P, Sczepanski B, Boensch M, Winterkamp S, Schonheit-Kenn U, Neurohr C, Behr J, Kenn K. Effects of inpatient pulmonary rehabilitation in patients with interstitial lung disease. Eur Respir J. 2013 Aug;42(2):444-53. doi: 10.1183/09031936.00081512. Epub 2012 Oct 25.

  PMID: 23100507 BACKGROUND

• Cox CE, Donohue JF, Brown CD, Kataria YP, Judson MA. The Sarcoidosis Health Questionnaire: a new measure of health-related quality of life. Am J Respir Crit Care Med. 2003 Aug 1;168(3):323-9. doi: 10.1164/rccm.200211-1343OC. Epub 2003 May 8.

  PMID: 12738606 BACKGROUND

• De Vries J, Michielsen H, Van Heck GL, Drent M. Measuring fatigue in sarcoidosis: the Fatigue Assessment Scale (FAS). Br J Health Psychol. 2004 Sep;9(Pt 3):279-91. doi: 10.1348/1359107041557048.

  PMID: 15296678 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.

  PMID: 6805625 BACKGROUND

• Parcell AC, Sawyer RD, Tricoli VA, Chinevere TD. Minimum rest period for strength recovery during a common isokinetic testing protocol. Med Sci Sports Exerc. 2002 Jun;34(6):1018-22. doi: 10.1097/00005768-200206000-00018.

  PMID: 12048331 BACKGROUND

MeSH Terms

Conditions

Sarcoidosis; Sarcoidosis, Pulmonary; Lung Diseases, Interstitial; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juliet Parry

  Kingston University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Senior Lecturer in Health & Exercise Prescription

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: November 8, 2017
• Study Start: November 7, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

GB (2)