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

NCT03193268 | Completed DMC

• 1 other identifier: IKEB0014/2015
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Parkinson Disease; Balance; Rehabilitation; Motor Function

Keywords

sensorimotor training; quality of life; posture

Outcome Measures

Primary Outcomes (4)

• EQ5D-5L

  Questionnaire

  0-5 scale (5 weeks-long, the higher score is better)

• Borg test

  Fatigue questionnaire

  0-40 point (5 week-long, higher score is better)

• PDQ-39

  special Parkinson's Disease test - motor and no-motor function

  0-39 scale (5week-long, higher score is better)

• SPPB test (gait, balance, leg stregth)

  Walking and balance testing

  0-12 scale (5 week-long, higher score is better)

Study Arms (3)

High intensity agility group

EXPERIMENTAL

Exercise therapy

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

Other: cycling

No-exercise control group

NO INTERVENTION

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

Interventions

Single-blind RTC of PD patients OTHER

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

High intensity agility group

cycling OTHER

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

Non-agility cycling group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe heart problems, severe demeanor, alcoholism, drug problems,

Sponsors & Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital: lead

Study Sites (1)

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Location

Related Publications (2)

• 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

Related Links

• Description Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investoigator

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 20, 2017
• Study Start: October 15, 2017
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: May 4, 2020

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)