The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis
Condition: Sarcoidosis; Sarcoidosis, Pulmonary; ILD; Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Observational

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.
    

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.
    

Intervention name(s): Exercise
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with known Pulmonary Sarcoidosis according to ATS/ERS/ WASOG criteria statement
        ascertained by self-reporting.
      
Keywords: Physical Activity; Diet; Exercise; Sarcoidosis; Pulmonary sarcoidosis; Lung Function; Fitness; Strength; Endurance