Committee on the Use of Human Subjects (CUHSR/IRB)

PROPOSAL ID:3621
TITLE:CHANGES IN SELF-REPORTED DEPRESSION, FATIGUE, QUALITY OF LIFE, AND PHYSICAL OUTCOMES FROM A COMMUNITY-BASED TANDEM CYCLING PROGRAM IN ADULTS WITH PARKINSON’S DISEASE
PRINCIPLE INVESTIGATOR:GERLACH, STEPHANIE
HEALTH, SPORT AND EXERCISE SCIENCE
8162714290
SGERLACH1@MISSOURIWESTERN.EDU
OTHER INVESTIGATORS:WILLIAM RUSSEL,RNSTEPHANIE STEWART,RNBAILEY GILBERT,RNPATRICK PINKINS
IRB SUMMARY: File Created: January 31, 2022
Department Chair Action Date: February 1, 2022
Current Status: Approved by CUHSR
Action Date: February 9, 2022
Approval Expiration Date: February 9, 2023
Confidentiality Data are linked to individuals.

STATEMENT OF PURPOSE

Parkinson’s disease (PD) is a neurodegenerative disease that affects the dopamine-producing brain cells in the basal ganglia of the brain. Dopamine is a chemical which is important for movement, and PD-mediated changes in dopamine levels can lead to several movement disorder symptoms such as bradykinesia, muscular rigidity, postural instability, slowness, stiffness, gait difficulties, and tremors (Cugusia et al., 2014). As a result of such symptoms, PD patients often experience memory problems, depression, and fatigue. Parkinson’s is a progressive disease with symptoms worsening over time (Abrantes et al., 2012). In addition, PD affects nearly 10 million adults worldwide, and this number is predicted to double by 2040 (Kowal et al., 2013). There are several noted PD outcomes that have a deleterious effect on one’s quality of life. One common outcome in PD patients is fatigue, however, it is often under-recognized by health care providers (Lou, 2015). For example, Shulman et al. (2002) demonstrated that physicians fail to identify the presence of fatigue, depression, and anxiety more than half of the time. Fatigue occurs at every stage of PD and worsens with disease progression. In addition, it is associated with other non-motor symptoms such as apathy, poor quality of life, depression, sleep disorders, and cognitive dysfunction (Lou, 2015). Depression is also present in 40% of PD patients (Ravina et al., 2007). Depression among PD patients appears to be associated with their overall well-being and health-related quality of life (HRQoL), cognitive impairment, and dementia (van Uem et al., 2016). Previous research suggests the presence of a wide spectrum of psychiatric conditions in PD, ranging from depressive disorders, anxiety disorders, and comorbid depression (Nuti et al., 2004; Quelhas & Costa, 2009). In addition, depression is the most common non-motor disturbance in PD patients (Papaetropoulos et al., 2006). Increased physical activity levels have been shown to be related to HRQoL in PD patients, with energy expenditure being a predictor of greater overall HRQoL and lower depression among PD patients (van Uem et al., 2018). Exercise has been shown to help PD patients’ in terms of improving motor function and mobility (Oliveira de Carvalho et al., 2018; Ridgel et al., 2015), clinical functions such as strength, gait, and balance (Lauzé et al., 2016), as well as patient-reported quality of life and mental health (Oliveira de Carvalho et al., 2018; Rafferty et al., 2017). Evidence has shown that exercise may be an effective strategy to delay or reverse physical function declines and decrease depression in PD patients (Kolk & King, 2013). In addition to the role exercise may have on positively affecting brain neurotransmitters, or in brain-derived neurotrophic factors (Dietrich & McDaniel, 2004), exercise can lead to improvements in self-esteem and sense of achievement (Biddle & Asare, 2011). Among research examining exercise benefits among PD patients, there has been increased interest on bicycle exercise modalities on the physical (Bellumori et al., 2014; McGough et al., 2016; Ridgel et al., 2012; Segura et al., 2020) and affective (Ridgel et al., 2010) outcomes of adults with PD. Specifically, the use of tandem bicycles has been used in research settings, where patients were cycling with a healthy individual who could ensure a certain speed (RPM) was attained during the exercise session. The cycling speed that has been shown to provide the largest improvements in PD patients is 80-90 rpm (McGough et al., 2016). A lower exercise intensity in the range of 3-4 rating of perceived exertion (RPE) on the 0-10 Borg scale is favored (McGough et al., 2016). The purpose of this study will be to examine the effects of a regular (twice weekly) tandem cycling program on Parkinson’s Disease (PD) patients’ self-reported fatigue, depression, and various functional outcomes.

STATEMENT OF RESEARCH METHODOLOGY

This project will be a non-randomized, repeated measures, quasi-experimental study design. All subjects will receive the same intervention as is common in studies including PD patients. There will be no control group. After an initial intake interview, screening for cardiovascular disease risk, and ensuring the participant fits the inclusion criteria and signing of an informed consent, PD patients will complete the GDS-15 questionnaire and the PFS-16 with the help of a research team member. Several physical function tests will be completed in the following order by each patient after completion of the questionnaires: Timed Up and Go (TUG) , Five time sit to stand, handgrip strength, and the Berg Balance Scale. Depression Geriatric Depression Scale (GDS). The short form GDS is a 15 item instrument for measuring depression. These 15 questions have been selected from the long form GDS, which has 30 questions, as they seem to have the highest correlation with depressive symptoms. The short form GDS has been used in various research in adults over 18 years of age, with and without chronic diseases. The scale has an overall 92% sensitivity and an 89% specificity to evaluate diagnostic criteria for depression (Greenberg, 2012). The sensitivity in PD patients aged 65-75 is 89%, and 90% in patients over the age of 75 (Weintraub, Saboe & Stern, 2007). The instrument has 10 questions that indicate depression when answered positively and 5 questions which indicate depression if answered negatively. A short form GDS score of 5-8 indicates mild depression, 9-11 moderate depression and 12-15 indicates severe depression. Fatigue Parkinson’s Disease Fatigue Scale (PFS-16). The PFS-16 (Brown et al., 2005) is designed to assess physical fatigue and its impact on the patients’ daily function. It is a 16-item self-report measure of patients’ subjective experience of fatigue over the last week. Patients are asked to rate the extent to which each statement describes their feelings and experiences. The PFS-16 uses a five-point Likert type scale ranging from strongly disagree to strongly agree. The PFS-16 has demonstrated satisfactory test-retest reliability and good specificity and sensitivity (Brown et al., 2005). An overall fatigue score will be calculated by obtaining the overall mean score across the 16 items. Functional Outcomes Timed-up-and-Go (TUG) Test- The TUG Test is used to assess functional mobility in older adults and has been used to assess functional outcomes in previous PD research (e.g., Cugusi et al., 2015). The patient sits in a chair without armrests. A mark on the floor indicates a distance of 3 meters. On the “go” signal from the administrator, the patient will stand up, walk to the mark, turn around and sit back down in the chair. The fastest time from 2 trials will be recorded and used as their measure of functional mobility. Five times sit to stand test - The Five Times Sit-to-Stand test (FTSST; Duncan, Leddy, & Earhart, 2011) is a measure of functional lower extremity strength. The patient sits in a chair without armrests, back supported and arms crossed over their chest. The patient is asked to stand up and sit down 5 times as fast as possible without taking breaks. The fastest time of two trials will be recorded and used as a measure of PD patients’ functional lower extremity strength. Handgrip strength - A dynamometer will be used to measure handgrip strength in the left and right hand. The dynamometer will be adjusted to fit the hand size of the patient before testing begins. The patient will then flex their arm at the elbow to 90% and squeeze the dynamometer as tight as possible. The same measure is repeated 3 times on each hand. The highest recording on each side will be noted. Berg Balance Test - This is a 14-item objective measure that assesses static balance and fall risk in adults (Qutubbin et al., 2005). As part of the test, patients are asked stand up from a chair, stand unsupported, sitting unsupported, standing to sitting, transfer, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving objects from floor, turning to look behind, turning 360 degrees, placing alternate foot on stool, standing with one foot in front, and standing on one foot. The patient is scored on a 0-4 scale on each of the 14 items. The interpretation is based on the points received in all items, with a score of 0-20 indicating wheelchair bound, 21-40 walking with assistance, and 41-56 independent. Cycling protocol All subjects will be asked to complete two cycling sessions weekly. There will be at least 48 hours between exercise sessions. Before and after each session, a resting blood pressure and heart rate measure will be taken to ensure subject safety. During a 5-minute warm-up during which cycling intensity (rpm) will gradually increase to a designated exercising intensity, subjects will be asked to cycle for 45 minutes at an RPE of 3-4 on 0-10 Borg scale. The duration of the cycling bout will increase to 45 minutes with time for subjects that cannot cycle for a total duration of 55 minutes (including warm-up and cool-down) at the beginning of the study participation. Based on the duration achieved in the first session, the cycling instructor will increase duration over a period of no more than 4 weeks to the desired duration of 55 minutes. Since cycling will take place on tandem bikes, a healthy individual (aged 19-35), who will serve as cycling partner for each participant, will ensure the cycling speed is maintained throughout the session. The cycling speed goal for each session will be 80 rpm, which will be achieved through the use of a metronome. Resistance will be adjusted individually to meet the desired RPE range. After 45 minutes, subjects will be asked to cycle at a lower intensity for an additional 5 minutes for cool-down. Each session will conclude with 5 minutes of whole body stretching. Each cycling session will be supervised by a member of the research team. Assessment of Affective Variable and Motor Functions After the initial screening including the questionnaires and the functional fitness tests, subjects will complete a twice weekly cycling protocol under supervision of a research team member. At six weeks (12 sessions) and after 12 weeks (24 sessions), subjects will again complete the questionnaires and functional fitness tests. The same researcher should complete testing at all three time points. Measuring depression, fatigue, and functional fitness at three time points will allow the research team to measure initial changes to depression, fatigue and functional fitness as well as additional changes due to long-term participation in an exercise program.

ANTICIPATED RISKS AND BENEFITS

The project has various risks and benefits for the subjects. There are inherent risks from the involvement in exercise. These include the risk for musculoskeletal injuries, risk of falls, and cardiovascular disease risk. However, the risk for cardiovascular disease during exercise is minimal, with a risk of 1 in 116,906 and 1 in 219,970 hours of exercise for cardiac arrest, and myocardial infarction respectively. The risk for a fatal event during exercise is 1 in 752,365 hours of exercise (American College of Sports Medicine, 2021). In order to mitigate the aforementioned risks, all possible subjects will be screened for cardiovascular disease risk according to the American College of Sports Medicine guidelines. Additionally, subjects must provide either medical clearance from their primary physician or must bring a support letter to exercise from their neurologist. In order to minimize the risk of falls, subjects will be assisted in getting on and off the tandem bicycle. To lower the risk for musculoskeletal injuries, a 5 minute warm-up will be completed at lower intensities to increase the body temperature and lower the injury risk. Benefits of regular aerobic exercise include the reduction in blood pressure, total and LDL cholesterol and body weight, as well as an increase in HDL cholesterol, insulin sensitivity, depressive symptoms, fatigue, exercise tolerance, and sleep among others (Myers, 2003). Improved health related quality of life, depression scores and in PD patients have been reported as a benefit of exercise (van Uem et al., 2018). Additionally, benefits for PD patients include improved gait speed, mobility function, strength, balance and mobility (Lauzé et al., 2016; Oliveira de Carvalho et al., 2018; Ridgel et al., 2015; Shulman et al., 2013). There is no financial compensation for participating in the study. Subjects can use the Freudenthal PD center without a charge or membership.

SUBJECT SELECTION

Adults with a diagnosis of PD (n = 30) will be recruited to participate in a tandem cycling program through a local Parkinson’s Disease organization (Freudenthal Center for Parkinson’s Disease) and through the referral from local neurologists within a radius of 60 miles of Saint Joseph, MO. Inclusion criteria for subjects will include; a diagnosis of PD, age 45-75 years, previously sedentary, able to walk 100 m (assistive device allowed), physician approval, and being able to attend twice weekly cycling sessions, this include ensuring transportation to the cycling facility. Subjects will maintain their pre-program activity level and any medication dosage during the study duration. Exclusion criteria will include a serious cardiac or pulmonary condition, diabetes mellitus, musculoskeletal contraindications, or a history of central nervous system disease other than PD. An initial interview with potential subjects will be used in which to identify possible exclusion criteria. During the cycling program, subjects will not participate in any other exercise training programs or physical therapy treatment. In addition, any Parkinson’s medication that subjects may take will be kept unchanged during the cycling program.

CONFIDENTIALITY

All data will be held confidential. Completed questionnaires, exercise testing data, cycling data and informed consents will be stored in a locked filing cabinet by the principal investigator. No data will be stored electronically or be shared. For data analysis, data will be entered into Excel but names will be replaced by a numeric code for each subject. Verbal approval for the study has been given by the Freudenthal director for the PD center, Stephanie Stewart.

PRIMARY SUPPORTING DOCUMENT

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IRB CHAIR COMMENTS

The proposal is approved pending some textual changes. Please provide an updated version of the proposal for our records when you send in the final signature confirmation. The chair will contact you with the specific recommendations in a subsequent email.

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