Parkinson DiseaseNCT03193268
Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
A study testing Single-blind RTC of PD patients and cycling in people with Parkinson Disease and Balance, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial summary
Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility. Hypothesis 1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Balance, Rehabilitation
- What is being tested?
- Single-blind RTC of PD patients and cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 15 Oct 2017to 21 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease,
- Hoenh Yahr scale of 2-3,
- instability problem,
Who cannot join
- Severe heart problems, severe demeanor, alcoholism, drug problems,
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Somogy Megyei Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400
About this study
Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.
Hypothesis
- The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.
- If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.
Read the detailed description
Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.
Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.
Control: No-exercise, measurment-only control group.
- Conditions
- Parkinson Disease, Balance, Rehabilitation, Motor Function
- Being tested
- Single-blind RTC of PD patients, cycling
- Keywords
- sensorimotor training, quality of life, posture
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-blind RTC of PD patientsOther
The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.
cyclingOther
Patients must undergo a daily exercise cycle of 1 hour during the intervention
| Study group | Role | What they receive |
|---|---|---|
| High intensity agility group | Experimental | Exercise therapy Receives: Other: Single-blind RTC of PD patients |
| Non-agility cycling group | Experimental | Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks Receives: Other: cycling |
| No-exercise control group | No intervention | Control Parkinson's disease control group thad will not receive exercise treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D-5L
Questionnaire
Measured: 0-5 scale (5 weeks-long, the higher score is better)
Borg test
Fatigue questionnaire
Measured: 0-40 point (5 week-long, higher score is better)
PDQ-39
special Parkinson's Disease test - motor and no-motor function
Measured: 0-39 scale (5week-long, higher score is better)
SPPB test (gait, balance, leg stregth)
Walking and balance testing
Measured: 0-12 scale (5 week-long, higher score is better)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start15 Oct 2017
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193268
- Sponsor's protocol ID
- IKEB0014/2015
- Status last verified
- Jul 2017
- First submitted
- 1 Jun 2017
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
- ClinicalTrials.gov ID
- NCT03193268
- Acronym / sponsor ID
- IKEB0014/2015
- Conditions
- Parkinson Disease, Balance, Rehabilitation, Motor Function
- Keywords
- sensorimotor training, quality of life, posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.
Hypothesis
- The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.
- If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.
Detailed description
Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.
Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.
Control: No-exercise, measurment-only control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity agility group | Experimental | Other: Single-blind RTC of PD patientsExercise therapy |
| Non-agility cycling group | Experimental | Other: cyclingParkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks |
| No-exercise control group | No intervention | –Control Parkinson's disease control group thad will not receive exercise treatment |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease,
- Hoenh Yahr scale of 2-3,
- instability problem,
Key exclusion criteria (1 listed)
- Severe heart problems, severe demeanor, alcoholism, drug problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-blind RTC of PD patientsThe groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period. | Other | High intensity agility group |
| cyclingPatients must undergo a daily exercise cycle of 1 hour during the intervention | Other | Non-agility cycling group |
Primary outcome
EQ5D-5L
Time frame: 0-5 scale (5 weeks-long, the higher score is better)
Questionnaire
Borg test
Time frame: 0-40 point (5 week-long, higher score is better)
Fatigue questionnaire
PDQ-39
Time frame: 0-39 scale (5week-long, higher score is better)
special Parkinson's Disease test - motor and no-motor function
SPPB test (gait, balance, leg stregth)
Time frame: 0-12 scale (5 week-long, higher score is better)
Walking and balance testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Description Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-blind RTC of PD patients and cycling in people with Parkinson Disease and Balance, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ5D-5L (time frame: 0-5 scale (5 weeks-long, the higher score is better)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.