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
| ISRCTN | ISRCTN13047118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13047118 |
| Secondary identifying numbers | ParkinsonTandem |
- Submission date
- 06/02/2018
- Registration date
- 08/02/2018
- Last edited
- 18/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Parkinson's disease is a frequent and progressive condition that causes shaking, difficulty walking and performing fine movements, and many other symptoms. Several drugs are currently available for the treatment of Parkinson's, but their effect is limited, so patients need more and better alternatives. Some studies have found that exercising might be good for people with Parkinson's, especially when it is done at a "forced rate", that is to say, causing the patient to out of their "comfort zone". Using a tandem stationary bicycle is a safe way of exercising for someone with Parkinson's. The aim of this study is to find out whether exercising on a tandem bicycle at a forced rate several times a week has a favourable effect on patients with Parkinson's disease.
Who can participate?
Patients aged 65 or older with Parkinson's disease
What does the study involve?
Participants are asked if they are able to regularly attend three high-intensity exercise sessions, including taking the time, expense, physical dedication and effort represented by this. Those who respond yes are allocated to the intervention group, and those who respond no are allocated to the control group. The control group receive usual care provided by their doctors. Participants in the intervention group receive usual care and also take part in a high-intensity tandem bicycle program: a 30-minute session consisting of a 10-minute warm-up followed by 20 minutes pedalling at 80 revolutions per minute or faster, three times a week over 16 weeks. Both groups are assessed before and after the intervention to measure the severity of their disease, the way their brain functions during movement with an MRI scan, and the blood levels of several markers of Parkinson's disease.
What are the possible benefits and risks of participating?
Possible benefits include improvements in general fitness and well-being, reductions in Parkinson’s disease symptoms, and improvements in some of the brain processes than have been altered by Parkinson’s disease. The potential risks include muscular aches or minor strains from practicing exercise, and a minor bruise at the site of blood draw.
Where is the study run from?
Fundación Santa Fe de Bogotá (Colombia)
When is the study starting and how long is it expected to run for?
June 2014 to September 2016
Who is funding the study?
1. Fundación Santa Fe de Bogotá (Colombia)
2. Universidad del Rosario (Colombia)
3. Universida de los Andes (Colombia)
Who is the main contact?
Dr Carlos O Mendivil
carlosolimpo@gmail.com
Contact information
Scientific
Carrera 7 No 116-05, Of 413
Bogotá
110111
Colombia
 ORCID ID |
0000-0001-5546-4206 |
|---|---|
| Phone | +57 (0)3394949, ext 1248 |
| carlosolimpo@gmail.com |
Study information
| Study design | Interventional parallel two-arm non-randomized single-center pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study hypothesis | A high-intensity tandem bicycle program may provide benefits on the clinical condition, biochemical markers and functional neuroimaging of patients with Parkinson's disease. |
| Ethics approval(s) | Corporate Committee on Research Ethics (IRB) of Fundación Santa Fe de Bogota, 25/11/2014, ref: CCEI-2342-2014 |
| Condition | Parkinson's disease |
| Intervention | Potential participants from the Hospital's Parkinson's disease clinic were asked if they would be able to regularly attend three high-intensity exercise sessions of the described characteristics, including taking the time, expense, physical dedication and effort represented by this. Those who responded yes were assigned to the intervention group, and those who responded no were assigned to the control group. After 8 weeks of physical conditioning, participants are allocated to: 1. Intervention group: Usual care plus a high-intensity tandem bicycle program: a 30-minute session consisting of a 10-minute warm-up followed by 20 minutes pedaling at 80 revolutions per minute or faster, three times a week over 16 weeks 2. Control group: Usual care provided by their doctors Both groups were assessed before and after the intervention for: 1. The severity of their disease 2. The way their brain was functioning during movement with an imaging technique (fMRI) 3. The concentration of several substances that reflect the degree of improvement or deterioration that may be occurring with their Parkinson's |
| Intervention type | Behavioural |
| Primary outcome measure | 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 | Measured before and right at the end of the 16-week intervention period: 1. Maximal oxygen consumption (VO2 max) 2. Body composition measures: BMI, % body fat, % lean mass, abdominal circumference 3. Cortical activations in functional Magnetic Resonance Imaging (fMRI) 4. Plasma concentrations of Parkinson's disease biomarkers: BDNF, PGDF-BB, Cathepsin-D, NGF, RANTES, ICAM-1 |
| Overall study start date | 01/06/2014 |
| Overall study end date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 14 |
| Total final enrolment | 13 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2015 |
| Recruitment end date | 01/03/2016 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Bogotá
110111
Colombia
Sponsor information
Hospital/treatment centre
Carrera 7 No. 117 – 15
Bogotá
110111
Colombia
| Phone | +57 (0)1 6030303 |
|---|---|
| info@fsfb.org.co | |
| Website | www.fsfb.org.co/ |
"ROR" |
https://ror.org/03ezapm74 |
University/education
Calle 12C No. 6-25
Bogotá
111711
Colombia
| Phone | +57 (0)1 2970200 |
|---|---|
| info@urosario.edu.co | |
| Website | www.urosario.edu.co/ |
University/education
Calle 19A # 1-37 Este
Bogotá
111711
Colombia
| Phone | +57 (0)1 3394949 |
|---|---|
| info@uniandes.edu.co | |
| Website | www.uniandes.edu.co |
Funders
Funder type
University/education
No information available
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Rosario, Rosario University, UR
- Location
- Colombia
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Once it is registered, it will be submitted to an internationally indexed, peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Carlos O Mendivil (carlosolimpo@gmail.com) and Dr Carolina Segura (carolinasegura2015@gmail.com). Type of data: anonymized primary data including group (intervention or control), demographics, baseline and final values of all study outcomes. When the data will become available: Data are already available and will remain available. By what access criteria data will be shared including with whom: Qualified researchers whose institutional affiliation we can verify. For what types of analyses: Whichever the researchers see fit. Whether consent from participants was obtained: consent was obtained from participants for the sharing of anonymized study data. There are no known ethical or legal restrictions in this concern. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/07/2020 | 18/08/2020 | Yes | No |
Editorial Notes
18/08/2020: Publication reference and total final enrolment number added.
