Back to resultsCompare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
Primary Purpose
Healthy, Movement Disorders, Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring balance, postural controll, motor controll, posturgraphy, quality of life
Eligibility Criteria
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
Sites / Locations
- József Tollár
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
Healthy cycling group
Healthy xbox group
Healthy controll group
PD groupe
Arm Description
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.
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.
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.
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
Outcomes
Primary Outcome Measures
Postural instability
Body sway (mm) (Posturography test)
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)
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 )
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)
Secondary Outcome Measures
depression scale
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)
Full Information
NCT ID
NCT03427762
First Posted
February 3, 2018
Last Updated
April 26, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University of Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03427762
Brief Title
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
Official Title
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 3, 2018 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University of Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Movement Disorders, Parkinson Disease, Condition
Keywords
balance, postural controll, motor controll, posturgraphy, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy cycling group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy xbox group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controll group
Arm Type
No Intervention
Arm Description
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.
Arm Title
PD groupe
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Other Intervention Name(s)
Healthy cycling group, Healthy xbox group, PD group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural instability
Description
Body sway (mm) (Posturography test)
Time Frame
5 weeks
Title
quality of life
Description
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)
Time Frame
5 weeks
Title
balance test
Description
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 )
Time Frame
5 weeks
Title
mobility test
Description
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)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
depression scale
Description
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)
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
József Tollár, MSC
Organizational Affiliation
Somogy Megyei Kaposi Mór Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
József Tollár
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
30973482
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=healthy+adult+training
Description
Related Info
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Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
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