NCT03427762

Brief Summary

The purpose of the study is to compare the effectiveness and specificity of agility and cycling exercise training on balance and mobility outcomes in PD and age and gender matched healthy controls. The hypothesis is that due to being profoundly deconditioned, agility and cycling will be similarly effective in PD but agility will be more effective then cycling in healthy old adults, in improving mobility and balance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

April 28, 2020

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 3, 2018

Last Update Submit

April 26, 2020

Conditions

Keywords

balancepostural controllmotor controllposturgraphyquality of life

Outcome Measures

Primary Outcomes (4)

  • Postural instability

    Body sway (mm) (Posturography test)

    5 weeks

  • quality of life

    EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)

    5 weeks

  • balance test

    Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )

    5 weeks

  • mobility test

    Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)

    5 weeks

Secondary Outcomes (1)

  • depression scale

    5 weeks

Study Arms (4)

Healthy cycling group

EXPERIMENTAL

During a 5-week intervention, we examine the patients' balance, postural control, quality of life and mobility. Then there is a bicycle every 1 hour.

Other: Rehabilitation

Healthy xbox group

EXPERIMENTAL

During a 5-week intervention, we examine the patients' balance, postural control, quality of life and mobility. Then they will train 1 hour every day on an xbox program.

Other: Rehabilitation

Healthy controll group

NO INTERVENTION

During a 5-week intervention, we examine the patients' balance, postural control, quality of life and mobility. Thereafter, the group does not move only in everyday life.

PD groupe

EXPERIMENTAL

Patients with PD have already been evaluated and compared to the results of a healthy group within a separate experiment. The study and the results have been completed. Clinical trial number:NCT03193268

Other: Rehabilitation

Interventions

Healthy cycling group: The group participates in 5 weeks of intensive cycling therapy. Healthy xbox group: The group participates in 5 week intensive xbox therapy Healthy controll group: The group does not take any kind of therapy. PD group: We have already analyzed the results of our group, and we will compare their results with the results of healthy groups.

Also known as: Healthy cycling group, Healthy xbox group, PD group
Healthy cycling groupHealthy xbox groupPD groupe

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family doctor should be qualified as healthy.
  • older adults had to have basic fitness
  • weekly movement of at least 3 hours

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

József Tollár

Kaposvár, Somogy County, 7400, Hungary

Location

Related Publications (1)

  • Tollar J, Nagy F, Moizs M, Toth BE, Sanders LMJ, Hortobagyi T. Diverse Exercises Similarly Reduce Older Adults' Mobility Limitations. Med Sci Sports Exerc. 2019 Sep;51(9):1809-1816. doi: 10.1249/MSS.0000000000002001.

Related Links

MeSH Terms

Conditions

Movement DisordersParkinson DiseaseDisease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • József Tollár, MSC

    Somogy Megyei Kaposi Mór Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2018

First Posted

February 9, 2018

Study Start

February 3, 2018

Primary Completion

April 15, 2018

Study Completion

May 10, 2018

Last Updated

April 28, 2020

Record last verified: 2018-02

Locations