Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility

NCT ID: NCT03193268

Last Updated: 2020-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2017-11-21

Brief Summary

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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 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.
2. 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

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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

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Parkinson Disease Balance Rehabilitation Motor Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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High intensity agility group

Exercise therapy

Group Type EXPERIMENTAL

Single-blind RTC of PD patients

Intervention Type OTHER

The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.

Non-agility cycling group

Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks

Group Type EXPERIMENTAL

cycling

Intervention Type OTHER

Patients must undergo a daily exercise cycle of 1 hour during the intervention

No-exercise control group

Control Parkinson's disease control group thad will not receive exercise treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Single-blind RTC of PD patients

The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.

Intervention Type OTHER

cycling

Patients must undergo a daily exercise cycle of 1 hour during the intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease,
* Hoenh Yahr scale of 2-3,
* instability problem,

Exclusion Criteria

• Severe heart problems, severe demeanor, alcoholism, drug problems,
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Somogy Megyei Kaposi Mór Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tollár József

Principal Investoigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Related Links

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Other Identifiers

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IKEB0014/2015

Identifier Type: -

Identifier Source: org_study_id

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