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SarcoidosisNCT03336736

The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis

An observational study of Sarcoidosis and Sarcoidosis, Pulmonary, run by Kingston University at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sarcoidosis, Sarcoidosis, Pulmonary, ILD
What is being tested?
Exercise
How many people
8 participants
Where
2 sitesUnited Kingdom
Study dates
7 Nov 2017to 15 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Applied & Human Sciences Human Performance Lab

    Kingston upon Thames, Surrey, KT1 2EE

  • Kingston University London

    Kingston upon Thames, Surrey, KT1 2EE

Other trials in United Kingdom

About this study

Official title: The Role of Non-pharmacological Rehabilitation Within Pulmonary Sarcoidosis: The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis

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.

Read the detailed description

This is a prospective cross-sectional observational project, with no intervention. All data will be self-reported and self-referred for voluntary participation. The participant information sheet and consent form will be provided in advance following interest of participation from the volunteers via email. In addition, on voluntary consent and approval of participation, the participant's general practitioner (GP) or consultant will be informed of their involvement in the study. Participants will be recruited via online forums, social media sources and via the newsletters /communication from Sarcoidosis organisations and Charities (e.g. The Sarcoidosis Charity; Sarcoidosis UK, Breathing Matters). Travel cost reimbursement will be offered to all participants who attend lab visits.

During visit one, participants will sign informed consent forms and have any questions answered before continuing. Baseline characteristics such as anthropometric data (stature, mass, heart rate (HR), blood pressure, age, BMI, fat% (Bodpod, Cosmed/ Bioelectric Impedance Analysis (BIA), Tanita) will be collected. Following this, participants will conduct a lung function test via computer spirometry (Oxycon Pro, VIASYS GmbH, Eric Jaeger, Hoechberg, Germany) and their predicted results will be corrected for ethnicity, allowing an accurate percentage of lung function to be recorded (Caucasian results remain the same, whilst Black-Caribbean are decreased by 13%). Participants will then conduct muscle strength testing of key muscle groups using an isokinetic dynamometer (Biodex System 4,Biodex Corporation, NY, USA); tests include: elbow flexor muscle strength (EFMS), quadriceps peak torque (QPT) and hamstring peak torque (HPT), in addition to this handgrip strength will also be assessed via handgrip digital dynamometer (Accord Medical Products; appendix XII). A minimum rest period of 20 minutes will follow based on exercise-based pulmonary rehabilitation research. Heart rate (bpm) will be checked at the end of this period and in two minute intervals until HR returns to baseline as per American College of Sport Medicine (ACSM) guidelines. Physical testing will not take place until this return to baseline. Following this rest period, participants will conduct a six-minute walk test (6MWT; appendix VIII). During the test participants will be measured for Borg rate of perceived exertion (appendix IX) and Borg Dyspnoea (appendix X) at 2 minute intervals and at completion of the test. Oxygen saturation (SO2) levels of participants will be recorded during the 6MWT via a portable pulse oximeter. Once the 6MWT has been completed participants will complete three questionnaires, the fatigue assessment scale (FAS; appendix IV), international physical activity questionnaire (IPAQ; appendix V) and Sarcoidosis Health Questionnaire (SHQ; Cox et al., 2003; appendix III). Before leaving, participants will be given a tri-axial accelerometer to wear on their hip (GT3X+ accelerometer, Actigraph) via a belt clip, which will be used to measure the participant's physical activity (PA) for seven days, to establish habitual physical activity levels and compare against the results of the IPAQ.

During the second lab visit, participants will return their accelerometers and following the same pattern of testing as the first visit, excluding the questionnaires (SHQ, FAS \& IPAQ) and anthropometric information. The order of testing will follow ACSM guidelines therefore strength and aerobic/anaerobic capacity will be first. Alongside this, age-matched healthy participants with no known interstitial lung disease (ILD) or other condition linked to reduced physical activity will used as a comparison between sarcoidosis and healthy normative values.

Procedural details:

  • Six Minute Walk Test: Performed along a straight flat 30 metre course indoors, participants walk at their own pace for 6 minutes. No warm-up is required however participants rest in the seated 10 minutes before the test in accordance with American Thoracic Society guidelines.
  • International Physical Activity Questionnaire (IPAQ): IPAQ comprises of 27 items across five activity domains asked independently.
  • Fatigue Assessment Scale (FAS): - FAS is a 10-item questionnaire with a 5-point Likert scale, it is split into 5 physical fatigue and 5 mental fatigue questions.
  • Sarcoidosis Health Questionnaire (SHQ): SHQ is a 29-item questionnaire with a 7-point Likert scale.
  • Borg rate of perceived exertion and Borg Dyspnoea: The Borg rate of perceived exertion scale (Borg RPE) allows participants to express how exerted they feel via a numbered scale, modified Borg Dyspnoea scale (Borg DS) allows participants to express their shortness of breath.
  • Distance Saturation Product (DSP): DSP is calculated by multiplying the distance a participant walks against their lowest oxygen saturation (Sp02) recorded during the 6MWT.
  • Oxygen saturation levels (SpO2): Oxygen saturation levels of participants will be recorded during the 6MWT via a portable pulse oximeter, the device will be fitted to the participant's finger and checked every 30 seconds throughout.
  • Isokinetic Dynamometer: A Biodex system will be utilized to look at dominant upper and lower limb strength via elbow flexor muscle strength (EFMS), quadriceps peak torque (QPT) and hamstring peak torque (HPT) tests, with rest periods of 60 seconds between repeated tests as per previous research findings.
  • Hand Dynamometer: Utilised to measure hand grip strength following ACSM guidelines.
  • Tri-axial Accelerometer: Participants will keep this on their persons throughout the time between their lab visits to measure real world physical activity for seven days.
Being tested
Exercise
Keywords
Physical Activity, Diet, Exercise, Sarcoidosis, Pulmonary sarcoidosis, Lung Function, Fitness, Strength, Endurance
Medical subject headings
Sarcoidosis, Sarcoidosis, Pulmonary, Lung Diseases, Interstitial, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseDiagnostic 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.

Study groups in NCT03336736
Study groupRoleWhat they receive
Pulmonary SarcoidosisSelf-reported and self-referred self-reported medically diagnosed pulmonary sarcoidosis. Exercise capacity and function will be assessed.
Receives: Diagnostic Test: Exercise
ControlHealthy age-matched control group with no known lung disease. Exercise capacity and function will be assessed.
Receives: Diagnostic Test: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    minutes of physical activity per day

    Measured: 7 days

Secondary outcomes (13)
  1. Functional exercise capacity

    Six-minute walk test (Distance in meters)

    Measured: 14 days

  2. Muscle strength (isokinetic dynamometer)

    Peak torque (Nm)

    Measured: 14 days

  3. Lung function using spirometry

    Lung volume (L/min)

    Measured: 14 days

  4. Quality of Life Score

    Patient reported health status using Sarcoidosis Health Questionnaire score

    Measured: 14 days

  5. Body Composition

    Body pat percentage (BF %)

    Measured: 1 day

  6. Anthropometric weight

    Body mass (kg)

    Measured: 1 day

  7. Anthropometric height

    body stature (cm)

    Measured: 1 day

  8. Cardiovascular Health

    Blood pressure (mmHg)

    Measured: 14 days

  9. Cardiovascular function

    Heart rate (bpm)

    Measured: 14 days

  10. Oxygen saturation

    SaP02 %

    Measured: 14 days

  11. Borg rate of perceived exertion

    RPE scale (6-20)

    Measured: 14 days

  12. Borg Dyspnoea

    Scale (0-10)

    Measured: 14 days

  13. Fatigue Assessment Scale

    Likert scale (1-5)

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start7 Nov 2017
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336736
Sponsor's protocol ID
KingstonUSport
Status last verified
Oct 2018
First submitted
19 Jul 2017
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The results of the study will form part of the researcher's Masters (MSc) by Research thesis and may be published anonymously in professional journals and/or as conference presentations.

Publications

  • 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.

    PubMed 27552344
  • 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.

    PubMed 25633076
  • 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.

    PubMed 25698652
  • 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.

    PubMed 20696064
  • 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.

    PubMed 26715771
  • 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.

    PubMed 23100507
  • 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.

    PubMed 12738606
  • 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.

    PubMed 15296678
  • 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.

    PubMed 12900694
  • 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.

    PubMed 6805625
  • 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.

    PubMed 12048331

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoidosis and Sarcoidosis, Pulmonary, run by Kingston University at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily physical activity measures against self-reported by tri-axial accelerometry (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336736, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.

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