Effect of a high-intensity tandem bicycle exercise program on clinical severity, functional magnetic resonance imaging and plasma biomarkers in Parkinson's disease: a pilot trial

Not Applicable

Completed

• Conditions: Parkinson's disease; Nervous System Diseases; Parkinson disease

• Registration Number: ISRCTN13047118
• Lead Sponsor: Fundación Santa Fe de Bogotá

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32793096/ (added 18/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-30
• Study Start: 2018-02-08
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Idiopathic PD confirmed by a movement disorder specialist
2. Hoehn & Yahr stage 1 to 3
3. Age 65 or younger
4. Stable dopaminergic therapy
5. A negative exercise stress test

Exclusion Criteria

1. Surgery for Parkinson's disease
2. Cancer
3. Musculoskeletal diseases
4. Coronary disease
5. Hyperthyroidism
6. COPD
7. Severe visual problems
8. History of stroke
9. Anemia
10. Use of anticoagulants
11. Use of a pacemaker
12. Use of an insulin pump
13. Mini-mental score below 24

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity, assessed using the Unified Parkinson's Disease Rating Score (UPDRS) before and right at the end of the 16-week intervention period

Secondary Outcome Measures

Name	Time	Method
<br> Measured before and right at the end of the 16-week intervention period:<br> 1. Maximal oxygen consumption (VO2 max)<br> 2. Body composition measures: BMI, % body fat, % lean mass, abdominal circumference<br> 3. Cortical activations in functional Magnetic Resonance Imaging (fMRI)<br> 4. Plasma concentrations of Parkinson's disease biomarkers: BDNF, PGDF-BB, Cathepsin-D, NGF, RANTES, ICAM-1<br>