HealthyNCT03427762
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
A study testing Rehabilitation in people with Healthy and Movement Disorders, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Movement Disorders, Parkinson Disease
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteHungary
- Study dates
- 3 Feb 2018to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- family doctor should be qualified as healthy.
- older adults had to have basic fitness
- weekly movement of at least 3 hours
Who cannot join
- Severe heart problems
- severe demeanor
- alcoholism
- drug problems
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy, Movement Disorders, Parkinson Disease, Condition
- Being tested
- Rehabilitation
- Keywords
- balance, postural controll, motor controll, posturgraphy, quality of life
- Medical subject headings
- Movement Disorders, Parkinson Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called Healthy cycling group, Healthy xbox group, PD group
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy cycling group | Experimental | 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. Receives: Other: Rehabilitation |
| Healthy xbox group | Experimental | 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. Receives: Other: Rehabilitation |
| Healthy controll group | No intervention | 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. |
| PD groupe | Experimental | 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 Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural instability
Body sway (mm) (Posturography test)
Measured: 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)
Measured: 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 )
Measured: 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)
Measured: 5 weeks
Secondary outcomes (1)
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)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start3 Feb 2018
- Primary completion15 Apr 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
- Investigators
- József Tollár, MSC, Principal investigator, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427762
- Sponsor's protocol ID
- IKEB009/2017
- Status last verified
- Feb 2018
- First submitted
- 3 Feb 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30973482
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
- ClinicalTrials.gov ID
- NCT03427762
- Acronym / sponsor ID
- IKEB009/2017
- Conditions
- Healthy, Movement Disorders, Parkinson Disease, Condition
- Keywords
- balance, postural controll, motor controll, posturgraphy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy cycling group | Experimental | Other: RehabilitationDuring a 5-week intervention, we examine the patients' balance, postural control, quality of life and mobility. Then there is a bicycle every 1 hour. |
| Healthy xbox group | Experimental | Other: RehabilitationDuring 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. |
| Healthy controll group | No intervention | –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. |
| PD groupe | Experimental | Other: RehabilitationPatients 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 |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- family doctor should be qualified as healthy.
- older adults had to have basic fitness
- weekly movement of at least 3 hours
Key exclusion criteria (4 listed)
- Severe heart problems
- severe demeanor
- alcoholism
- drug problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationAlso: Healthy cycling group, Healthy xbox group, PD groupHealthy 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 | Healthy cycling group, Healthy xbox group, PD groupe |
Primary outcome
Postural instability
Time frame: 5 weeks
Body sway (mm) (Posturography test)
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)
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 )
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)
1 secondary outcome
depression scale
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Derived from this study: PubMed 30973482Tollar 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.
- Related InfoLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
József Tollár, MSC principal investigator
Somogy Megyei Kaposi Mór Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Healthy and Movement Disorders, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural instability (time frame: 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.