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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03427762
Other study ID # IKEB009/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2018
Est. completion date May 10, 2018

Study information

Verified date February 2018
Source Somogy Megyei Kaposi Mór Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date May 10, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Hungary József Tollár Kaposvár Somogy

Sponsors (2)

Lead Sponsor Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital University of Groningen

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural instability Body sway (mm) (Posturography test) 5 weeks
Primary 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
Primary 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
Primary 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 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) 5 weeks
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