Interstitial Lung Disease Clinical Trial
Official title:
The Role of Non-pharmacological Rehabilitation Within Pulmonary Sarcoidosis: The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis
Verified date | October 2018 |
Source | Kingston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with known Sarcoidosis according to ATS/ERS/ WASOG criteria statement - Written informed consent is obtained. - Access to a computer with Internet Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Applied & Human Sciences Human Performance Lab | Kingston Upon Thames | Surrey |
United Kingdom | Kingston University London | Kingston upon Thames | Surrey |
Lead Sponsor | Collaborator |
---|---|
Kingston University |
United Kingdom,
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. — View Citation
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. — View Citation
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. Epub 2003 May 8. — View Citation
Craig CL, Marshall AL, Sjöström 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. — View Citation
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. — View Citation
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. Review. — View Citation
Huppmann P, Sczepanski B, Boensch M, Winterkamp S, Schönheit-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. — View Citation
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. — View Citation
Karadalli MN, Bosnak-Güçlü M, Camcioglu B, Kokturk N, Türktas 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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily physical activity measures against self-reported by tri-axial accelerometry | minutes of physical activity per day | 7 days | |
Secondary | Functional exercise capacity | Six-minute walk test (Distance in meters) | 14 days | |
Secondary | Muscle strength (isokinetic dynamometer) | Peak torque (Nm) | 14 days | |
Secondary | Lung function using spirometry | Lung volume (L/min) | 14 days | |
Secondary | Quality of Life Score | Patient reported health status using Sarcoidosis Health Questionnaire score | 14 days | |
Secondary | Body Composition | Body pat percentage (BF %) | 1 day | |
Secondary | Anthropometric weight | Body mass (kg) | 1 day | |
Secondary | Anthropometric height | body stature (cm) | 1 day | |
Secondary | Cardiovascular Health | Blood pressure (mmHg) | 14 days | |
Secondary | Cardiovascular function | Heart rate (bpm) | 14 days | |
Secondary | Oxygen saturation | SaP02 % | 14 days | |
Secondary | Borg rate of perceived exertion | RPE scale (6-20) | 14 days | |
Secondary | Borg Dyspnoea | Scale (0-10) | 14 days | |
Secondary | Fatigue Assessment Scale | Likert scale (1-5) | 14 days |
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