Parkinson's Improvement Activated by Hula Understanding (PAHU) - Part 2

3.1 OVERALL STUDY DESIGN AND METHODS This is a prospective cohort study that will investigate the efficacy of a 12-week group hula program for individuals with PD. Participants will be randomized to either a control or intervention group.

Twelve weeks after the baseline visit, participants in the control group will receive 12 weeks of the group hula program. The intervention group will begin the hula intervention at week 1 of the program and then go on to receive an additional 12 weeks of classes for a total of 24 weeks of the hula intervention. From week 14-26 the two hula classes will be held separately: one class for the control group and one for the intervention group.

The hula classes will be delivered in a group setting at QMC and will be led by wxperienced kumu. The hula program will consist of hula classes that will be for an hour, once a week for 3 months (a total of 12 classes). The hula program that was developed and tailored for individuals with PD in the PAHU study will be utilized.

Table 1. PAHU Hula Program Class Overview Phase Duration Exercises Goals/Benefits Grounding 5 min Breath work Promotes mindfulness, awareness of breathing and posture Cultural protocol 2-5 min Oli (chant) Encourages use of various pitches, breath, and vocal strengthening Warm-up (with music) 5-10 min Seated stretching of neck, limbs and trunk Engages muscles, loosens rigidity Song: Verse 1 20-25 min Standing hula or hula noho (seated) Reinforces movements + balance and activates dual tasking (singing and dancing) Water break 2-5 min Re-focuses attention to mind and body Song: Verse 2 20-25 min Standing hula or hula noho (seated) Prompts recall of 1st verse and steps Cool-down 5-10 min Sing mele (song) with options to sit, stand, or walk around space Provides chance for socialization, smiling, and eye-contact amongst group

If participants provide additional consent, video recordings that may contain identifiable features (e.g., their faces) will be collected from hula classes and study visits. The purpose of these videos is for future marketing, dissemination, and sharing of results but the content of the videos will not be used directly for research purposes.

6.2. STUDY VISIT SCHEDULE This study will involve 3 in-person research visits: baseline visit, follow-up visit 1 (week 12-14) and follow-up visit 2 (week 26-28).

6.2.1. Baseline Data Collection The research team staff will assist with informed consent and collect baseline data: demographic and medical history. The research associates will then schedule the baseline visit with the participant.

Demographics (collected from subject directly; medical records may be accessed for items the subject is not able to answer)

• Age
• Gender
• Self-identified race/ethnicity
• Detail of Lineage
• Religious affiliation
• Marital Status
• Highest level of education
• Work status
• Household income
• Health insurance
• Type of residence
• Island of residence
• Zip code Clinical Data (via medical records, patient's providers, and patients)
• Year of first symptoms (as confirmed by history obtained by the physician)
• PD diagnosis
• Time to diagnosis
• Diagnostic features/Criteria
• Motor symptoms
• Ambulatory/axial difficulties
• Side of body with initial symptoms
• Comorbidities
• Medications
• Advanced treatment
• Ancillary services

6.2.2. Baseline Visit At the baseline visit, the research team staff will assist with the completion of the QoL questionnaires as the subject has not yet been randomized.

The following activities will be performed in the following order:

• Review and completion of informed consent. Written informed consent may be completed on hard copy in-person or remotely (see Appendix A).
• Assignment of subject ID number. Research team member will enter ID into enrollment log.
• Gathering of demographic and medical history information.
• Completion of HRQoL questionnaires (PDQ-39, WEMWBS-14, SEMCD-6, MDS-NMS--Q, VHI-10)- any member of the research team.
• Completion of the UPDRS-III by a fellowship trained movement disorder specialist (Dr. Bruno or Dr. Gao).
• Completion of movement/balance measures (FOG-Q, 4SST, FTSTS, Quantitative Romberg Force Plate test) by Michael Yee, MS.

6.2.3. Follow-up Visits 1 (Week 12-14) & 2 (Week 26-28) At follow-up visits, only those who are blinded to the subject's study arm will administer measures.

The following activities will be performed:

• Completion of QoL questionnaires (PDQ-39, WEMWBS-14, SEMCD-6, MDS-NMS-Q, VHI-10) - Dr. Bruno, Dr. Gao or Michael Yee, MS.
• Completion of the UPDRS-III by a fellowship trained movement disorder specialist (Dr. Bruno or Dr. Gao).
• Completion of movement/balance measures (FOG-Q, FSST, FTSST, Quantitative Romberg Force Plate test) by Michael Yee, MS.

• STATISTICAL METHODS A. Power/Sample Size Considerations Since this is an exploratory pilot study, investigators have no sample size estimate. Investigators will collect data on approximately 30-40 participants. As such, the analysis is descriptive, and there is no statistical hypothesis to prove.

B. Statistical Analysis Plan Designed as a feasibility pilot study, our recruitment goal (30-40 participants enrolled) is pragmatic and based on a combination of factors, including timeline and availability of space. Although not properly powered, investigators will compare motor and non-motor measures.

Investigators will use descriptive statistics to evaluate recruitment, retention and resource utilization data. The data will be stored and organized in Microsoft Excel. Investigators will use descriptive statistics to describe the cohort.

Inclusion criteria

• Primary diagnosis of idiopathic PD confirmed by a movement disorder specialist.
• ≥ 18 years of age
• Ability to provide informed consent
• Ability to participate in an in-person 24-week hula program.
• Ability to complete all 3 balance tests (4SST, FTSTS, Quantitative Romberg Force Plate Measurement)

Exclusion criteria

• Presence of physical or mental health co-morbid conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow-up requirements, or impact the scientific soundness of the clinical trial results.
• Drug or alcohol dependence that might interfere with safe participation, based on opinion of the PI.
• Inability to attend in-person hula classes and study visits at QMC.
• Patients with high fall risk.
• Contraindications for physical activity and/or hula classes specifically.