Participants randomized to aerobic exercise

Participants randomized to usual care with PD specific health education

Parkinson's Disease

The investigators will use self-administered continuous walking exercise at a moderate intensity level, defined as 40-59% of heart rate reserve or 64-77% of heart rate at gas exchange threshold (HRGET) by ACSM as in the investigators' preliminary study (PMID: 24991037 PMCID: PMC4132568). The HRGET will be determined as the heart rate at VO2max during graded cycle ergometry. The total duration of the exercises will be 150 min/week per 2008 Physical Activity Guidelines for Americans and American Heart Association recommendations, conducted in three 50 min sessions. The aerobic walking intervention will take place outdoors (e.g., trails, sidewalks, parks) or indoors (e.g., track in a local gym or a mall) depending on the preferences of the subject and weather. Session duration will be 20 min the first week and will be advanced by 5 min per week over 6 weeks.

Aerobic walking

In this study, patients will receive their usual medical treatment for motor and non-motor symptoms from their
primary neurologist. The investigators will use a streamlined form of PD specific health education prepared by the VA: My Parkinson's Story, which consists of a series of short videos prepared by the VA PADRECCs addressing various aspects of PD. These 6-12 minutes long videos are freely available on YouTube. The investigators can also provide them on a CD if subjects desire. They start with a patient testimony about the topic of the episode, followed by comments of experts in the field. The title of the episodes are: Early Parkinson's, Medications, Exercise, Memory, Visual Disturbances, Depression, Sleep, Speech and Swallowing, Impulsive Behaviors, Driving, Pain, Dyskinesias, Deep Brain Stimulation, Advanced Parkinson's Disease, Falls, The Caregiver, Hospitalization, Genetics, Environmental Exposure, Atypical Parkinsonism

Usual care with PD specific health education

University of Iowa Hospitals & Clinics

Iowa City VA Health Care System, Iowa City, IA

Aerobic Exercise in Parkinson's Disease

Long Term Aerobic Exercise to Slow Progression in Parkinson's Disease

Motor function. MDS-UPDRS motor examination subscale (Part III) score in the "practically defined OFF state", i.e., after overnight (~12 hours) withdrawal of PD medications. Higher scores worse. Range: 0-132.

Cognitive function. Due to its sensitivity to changes in aerobic fitness (including in the investigators' preliminary study), the investigators chose change in Percent Increase Score (PIS) on Eriksen's flanker task, which measures the cost of conflict resolution between the incongruent and congruent stimuli. Higher scores worse.

Driving. The video of a standardized experimental drive in an instrumented vehicle will be scored for safety errors by a certified driving instructor. Higher scores worse.

Brain tissue integrity. The investigators will analyze differences in regional rD (radial diffusivity) changes between the aerobic exercise and usual care control groups in primary outcome regions of interest (Putamen, Cingulum, Superior Longitudinal Fasciculus). Higher scores worse.

Non-motor symptoms. Higher scores worse. Range: 0-48

Motor function. Higher scores worse. Range: 0-132.

Cognitive function. COGSTAT, a composite measure of cognition, calculated by assigning and summing standard T-scores (mean=50, SD=10) to eight tests from the cognitive test battery the investigators used in the driving studies, will be the main secondary outcome measure. This cognitive battery will enable us to probe multiple domains: Complex Figure Test-Copy (CFT-Copy) Version, Block Design for visuospatial construction; Trail-making Test (B-A), a measure of set shifting and Controlled Oral Word Association Test (also tests language) for executive functions; Rey Auditory Verbal Learning Test (anterograde verbal memory), CFT-Recall is administered 30 minutes after the CFT-Copy (visual memory), Benton Visual Retention Test errors for memory; Judgment of Line Orientation for visual perception. Higher scores worse.

Brain tissue integrity. Motor: Substantia nigra <-> putamen (nigrostriatal tract) and putamen <-> premotor cortex Cognitive: Dorsal lateral prefrontal cortex (DLPFC) <-> caudate and the parietal cortex <-> prefrontal cortex. Higher scores worse.

Severity of depression. Higher scores worse. Range: 0-15

Motor function. Higher scores worse. Range:0-52.

Anxiety severity. Higher scores worse. Range: 0-63

Sleep quality. Higher scores worse. Range: 0-60

Severity of fatigue. Higher scores worse. Range: 9-63

Average between two trials of oscillating finger tapping for both hands.

Motor function. Endurance (6-minute walk).

Changes of ability to complete activities of daily living. Lower percentage of ability worse. Range: 0-100%

Cognitive and memory. Lower scores worse. Range: 0-30

Vision. Sensitivity to contrast changes of letters. Range: 0.00 - 2.25

Visual acuity test. Changes of ETDRS Acuity Log Score.

Cardiorespiratory fitness as an index of aerobic exercise intervention delivery. Higher scores better.

Final datasets underlying all publications resulting from the proposed research will be shared outside VA.
Final data sets underlying publications resulting from this research will be shared upon written request and through ClinicalTrials.gov and databank/repository if specified by the VA.
Individuals can download the data and analyze the results using methods described in the investigators' articles or alternative methods as necessary.

VA Office of Research and Development

University of Iowa

One-year, single-blind, parallel group, randomized controlled trial (RCT) that compares the effects of moderate aerobic exercise vs. usual care + health education

Due to nature of the intervention (exercise), the participant cannot be blinded. However, assessors for various outcomes will be blinded to the group status.

A respresentative population of 275 Liberian children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Burkinabé children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Bangladeshi children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

Severe Acute Malnutrition

Action Against Hunger, Bangladesh

Action Contre la Faim, Burkina Faso

Action Against Hunger, Liberia

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

OptiDiag: Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin.

Describe and compare the different types of SAM anthropometric diagnoses based on Stable Isotope Analysis (SIA)

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs at admission; these include: dehydration, visible signs of wasting, pulse, signs of micronutrient deficiency, acute resipiratory infections, respiratory rate, temperature, dermatosis and hair changes and diarrhea.

Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance (BI).

Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.

Describe and compare the different types of SAM anthropometric diagnoses based on the history of lipid and protein catabolism (δ13C and δ15N isotopes in hair) reversed throughout nutritional rehabilitation.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs for dehydration at admission and the development of clinical signs of dehydration during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of visible wasting at admission and the development of clinical signs of visible wasting during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal pulse at admission and the development of abnormal pulse during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of micronutrient deficency at admission and the development of clinical signs of micronutrient deficency during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of acute respiratory infection at admission and the development of clinical signs of acute respiratory infection during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal respiratory rate at admission and the development of clinical signs of abnormal respiratory rate during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal temperature at admission and the development of clinical signs of abnormal temperature during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of dermatosis at admission and the development of clinical signs of dermatosis during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of hair change (color and consistency) linked to acute malnutrition at admission and the development of clinical signs of of hair change (color and consistency) during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of diarrhea at admission and the development of diarrhea during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on negative and positive treatment outcomes; these include: discharged from program as recovered [mid-upper arm circumference (MUAC) ≥ 125 and weight-for-height Z-score (WHZ) ≥ -2], defaulted from program (caretaker confirmation of unwillingness to participate), death, transfer to an in-patient facility (developement of medical complications as per national protocol, loss of or static weight), transfer to another out-patient facility outside of the program catchment area and facility and non-response to treatment (cure criteria unattained before maximum treatment duration).

Describe and compare the different types of SAM anthropometric diagnoses based on early weight gain.

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance.

Measures of household wealth reflected by durable assets, source of water supply, sanitation favility, type of floor material, type of cooking fuel, transportation, livestock, homestead or land area, bank account, number of family members per sleeping room.

The HFIAS is composed of a set of nine questions that have been used in several countries and appear to distinguish food insecure from food secure households across different cultural contexts.

Individual dietary diversity scores (IDDS) validated for age/sex groups.

esterase/умор

Aerobic Exercise in Parkinson's Disease

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

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