Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults

April 26, 2020 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • József Tollár

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy cycling group
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 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.

Other Names:
  • Healthy cycling group
  • Healthy xbox group
  • PD group
Experimental: Healthy xbox group
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 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.

Other Names:
  • Healthy cycling group
  • Healthy xbox group
  • PD group
No Intervention: Healthy controll group
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.
Experimental: PD groupe

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

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.

Other Names:
  • Healthy cycling group
  • Healthy xbox group
  • PD group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural instability
Time Frame: 5 weeks
Body sway (mm) (Posturography test)
5 weeks
quality of life
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression scale
Time Frame: 5 weeks
Beck Depression scale (The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression)
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Collaborators

University of Groningen

Investigators

  • Principal Investigator: József Tollár, MSC, Somogy Megyei Kaposi Mór Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2018

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

February 3, 2018

First Submitted That Met QC Criteria

February 3, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 26, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKEB009/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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