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

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: Healthy; Parkinson Disease; Movement Disorders; Condition
• Intervention / Treatment: Other: Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• 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

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

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: quality of life; balance; postural controll; motor controll; posturgraphy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Movement Disorders
• 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