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Table 3 Timeline of schedule of activities for Study in Parkinson Disease of Exercise (SPARX3) trial

From: Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial

 

Pre-Screen

Screening 1

Screening 2

Baseline

Month 1

Month 2

Month 3

Month 4

Month 5

Month 6

Month 7

Month 8

Month 9

Activity

 Pre-Screen (phone or clinic)

X

            

 Informed Consent

 

X

           

 Demographics

 

X

           

 General & PD Medical History

 

X

           

 Physical/Neurological Exam

 

X

       

X

   

 PD/Non-PD Medication Logs

 

X

 

X

  

X

  

X

  

X

 Beck’s Depression Inventory (BDI-II)

 

X

           

 Montreal Cognitive Assessment

 

X

       

X

   

 Blood Draw for Exercise Clearance

 

X

           

 DaTscan™ SPECT

  

X

          

 DaTscan™ Safety Follow-Up

  

X

          

 Inclusion/Exclusion Review

 

X

X

X

         

 MDS-UPDRS (I, II, III, IV) with H&Y

   

X

  

X

  

X

  

X

 Schwab and England

   

X

  

X

  

X

  

X

6-Min Walk Test with OPALS

   

X

     

X

   

 Activity Monitor (daily steps)

  

X

   

X

  

X

  

X

 Neuro-QOL

   

X

     

X

   

 PDQ-39

   

X

     

X

   

 VO2peak

   

X

     

X

   

 Blood Draw for Biomarkers

   

X

     

X

   

 Health Status Update

   

X

X

X

X

X

X

X

X

X

X

 Modified Health Status Update

             

 Exercise Confidence Beliefs & Goals

   

X

         

 Randomization

   

X

         

 PD Therapy Warranted

         

X

   

 Patient Global Impression of Change

         

X

   

 Clinician Global Impression of Change

         

X

   

 Intervention: 4×/week treadmill exercise

    

X

X

X

X

X

X

X

X

X

 Exercise Supervision & HR Data Verification

    

X

X

X

X

X

X

X

X

X

 Treadmill Speed & Incline

      

X

  

X

  

X

 Intervention Initiation

    

X

        

 Study Discontinuation/Completion

             

 Patient Stipend

 

X

X

X

  

X

  

X

  

X

 

Month 10

Month 11

Month 12

Month 13

Month 14

Month 15

Month 16

Month 17

Month 18

Months 19-23

Month 24

Symptomatic Tx

Activity

 Pre-Screen (phone or clinic)

            

 Informed Consent

            

 Demographics

            

 General & PD Medical History

            

 Physical/Neurological Exam

  

X

     

X

   

 PD/Non-PD Medication Logs

  

X

     

X

  

X

 Beck’s Depression Inventory (BDI-II)

            

 Montreal Cognitive Assessment

  

X

     

X

   

 Blood Draw for Exercise Clearance

            

 DaTscan™ SPECT

  

X

         

 DaTscan™ Safety Follow-Up

  

X

         

 Inclusion/Exclusion Review

            

 MDS-UPDRS (I, II, III, IV) with H&Y

  

X

     

X

 

X

X

 Schwab and England

  

X

     

X

 

X

X

6-Min Walk Test with OPALS

  

X

     

X

   

 Activity Monitor (daily steps)

  

X

  

X

  

X

   

 Neuro-QOL

  

X

     

X

 

X

 

 PDQ-39

  

X

     

X

 

X

 

 VO2peak

  

X

     

X

   

 Blood Draw for Biomarkers

  

X

     

X

 

X

 

 Health Status Update

X

X

X

X

X

X

X

X

X

   

 Modified Health Status Update

         

X

X

 

 Exercise Confidence Beliefs & Goals

            

 Randomization

            

 PD Therapy Warranted

  

X

     

X

  

X

 Patient Global Impression of Change

  

X

     

X

   

 Clinician Global Impression of Change

  

X

     

X

   

 Intervention: 4×/week treadmill exercise

X

X

X

X

X

X

X

X

X

   

 Exercise Supervision & HR Data Verification

X

X

X

X

X

X

X

X

X

   

 Treadmill Speed & Incline

  

X

     

X

   

 Intervention Initiation

            

 Study Discontinuation/Completion

          

X

 

 Patient Stipend

  

X

     

X

 

X

X

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Trials

ISSN: 1745-6215