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

Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03427762
Collaborator
University of Groningen (Other)
3
1
4
3.2
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
Actual Study Start Date :
Feb 3, 2018
Actual Primary Completion Date :
Apr 15, 2018
Actual Study Completion Date :
May 10, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Postural instability [5 weeks]

      Body sway (mm) (Posturography test)

    2. quality of life [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)

    3. balance test [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 )

    4. mobility test [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)

    Secondary Outcome Measures

    1. depression scale [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 József Tollár Kaposvár Somogy Hungary 7400

    Sponsors and Collaborators

    • Somogy Megyei Kaposi Mór Teaching Hospital
    • University of Groningen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Tollár József, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital
    ClinicalTrials.gov Identifier:
    NCT03427762
    Other Study ID Numbers:
    • IKEB009/2017
    First Posted:
    Feb 9, 2018
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tollár József, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2020