Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorVA Office of Research and Development

About this trial

Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

MoCA score >17

Able to walk with or without an assistive device at least 10 feet

Best corrected/aided acuity better than 20/70 in the better eye

Willingness to be randomized to a treatment group

Disqualifiers

Untreated Major Depression and major psychiatric illness

History of stroke, or traumatic brain injury

Pure-tone threshold average sensitivity at 0.5, 1.0,and 2.0 kHz exceeds 40 dB

Alcohol abuse and/or use of antipsychotics

Trial design

Design model

Parallel

Treatments tested in this trial

  • HV-PDAE: High Volume Partnered Dance Aerobic Exercise

    Behavioral

    HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 105h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

  • MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise

    Behavioral

    MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 105h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

  • MV-WALK: Moderate Volume Walking

    Behavioral

    MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. All participants will receive 105 h of training. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.

  • HV-WALK: High Volume Walking

    Behavioral

    HV-WALK classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 6300 minutes (105 h) of training. WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 90 minute sessions will consist of 25 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training evidence that light-moderate intensity walking programs can lead to gains in gait parameters.

Treatment groups

123 Participants
are divided into 4 treatment groups
Group A: HV-PDAE: High Volume Partnered Dance Aerobic ExerciseExperimental treatment 1 intervention
Group B: MV-PDAE: Moderate Volume Partnered Dance Aerobic ExerciseActive comparator 1 intervention
Group C: MV-WALK: Moderate Volume WalkingActive comparator 1 intervention
Group D: HV-WALK: High volume walkingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gait cadence

Gait Cadence is the number of human steps taken per minute while walking.

Time frame
52 weeks
2

Physical activity scale for the elderly (PASE)

This questionnaire is very comprehensive and assesses an older adults' activity level within the previous week by totaling their involvement in a variety of physical activities. The minimum score is 0 and the maximum score is 400. Higher scores indicate better outcomes.

Time frame
52 weeks
3

vascular function: Pulse wave velocity and Aortic index

Pulse wave velocity and augmentation aortic index are valid and reliable measures of vascular function. Pulse-wave velocity (PWV) is a measurement of arterial stiffness and is an independent predictor of cardiovascular risk. It can be assessed simply and noninvasively by measuring the carotid and femoral pulse pressures and the time delay between the two or by other methods relying on pulse-wave analysis.

Time frame
52 weeks

Secondary outcomes

1

inflammatory cytokine expression: Brain derived neurotrophic factor and c-reactive protein

BDNF: This neurotrophic factor plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory. Other studies have shown it increased in expression after structured long term exercise in populations with neurodegenerative disease. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.

Time frame
52 weeks
2

VO2 max- maximum oxygen consumption

Vo2 max is the maximal amount of oxygen that someone can use during intense or maximal exercise. It is a good indicator of cardiovascular fitness and aerobic endurance.

Time frame
52 weeks
3

inflammatory cytokine expression: and c reactive protein

These are both blood biomarkers derived from serum. Inflammatory cytokine expression: An inflammatory cytokine is a type of cytokine (a signaling molecule) that is secreted from immune cells and certain other cell types that promotes inflammation. Inflammatory cytokines are predominantly produced by T helper cells (Th) and macrophages and involved in the upregulation of inflammatory reactions. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.

Time frame
52 weeks
4

Six minute walk test

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Time frame
52 weeks

Other outcomes

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