Parkinson DiseaseNCT03902990
The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease
A study testing Dual task, Treadmill Training and Standard exercise programme in people with Parkinson Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dual task, Treadmill Training and Standard exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Apr 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with Idiopathic Parkinson Disease on medication who has
- Hoehn-Yahr 1-3
- Mini Mental Test score 20 and above
- Functional Ambulation Category 2 and above
- No changes in medication in last 3 months
- No rehabilitation programme in last 3 months
Who cannot join
- Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
- Global aphasia
- Severe cognitive dysfunction
- Other neurologic/orthopedic diseases
- Limiting cardiovascular or pulmonary disease
- Visual impairment
- Hearing loss
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
About this study
Official title: Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.
- Conditions
- Parkinson Disease
- Being tested
- Dual task, Treadmill Training, Standard exercise programme
- Keywords
- dual task, treadmill, cognitive rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual taskOther
The patients in the dual task group received cognitive tasks during treadmill training sessions.
Treadmill TrainingOther
Standard treadmill training
Standard exercise programmeOther
Standard exercise programme for Parkinson Disease
| Study group | Role | What they receive |
|---|---|---|
| Dual task | Experimental | Treadmill training + cognitive tasks + standard exercise programme Receives: Other: Dual task; Other: Treadmill Training; Other: Standard exercise programme |
| Single task | Active comparator | Treadmill training + standard exercise programme Receives: Other: Treadmill Training; Other: Standard exercise programme |
| Control | Active comparator | Standard exercise programme Receives: Other: Standard exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT
10 Meter Walk Test on comfortable speed
Measured: 12 weeks
10MWT with cognitive tasks
10 Meter Walk Test with cognitive tasks
Measured: 12 weeks
MoCA
Montreal Cognitive Assessment
Measured: 12 weeks
TUG
Timed Up and Go Test
Measured: 12 weeks
Secondary outcomes (5)
PDQ-39
Parkinson Disease Questionnaire 39
Measured: 12 weeks
FES-I
To evaluate fear of falling, all patients filled the Falls Efficacy Scale-International (FES-I). A series of 16 questions assesses the respondent's fear of falling for a range of ADLs. Each question was rated on a four-point scale.
Measured: 12 weeks
Stroop Test
Cognitive assessment for executive functions
Measured: 12 weeks
FOGQ
Freezing of Gait Questionnaire
Measured: 12 weeks
Falls Diary
Falls account
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Oct 2018
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Model description
- In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Kocamal, Istanbul University
- Investigators
- Ayse Yaliman, Prof, Study director, Istanbul University Istanbul Faculty of Medicine Physical Medicine and RehabilitationEkin Ilke Sen, MD, Study director, Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902990
- Sponsor's protocol ID
- 20181443
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual Task Training And Treadmill Training on Physical and Cognitive Functions in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT03902990
- Acronym / sponsor ID
- 20181443
- Conditions
- Parkinson Disease
- Keywords
- dual task, treadmill, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 4 Apr 2019 (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 ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Dual task | Experimental | Other: Dual task, Other: Treadmill Training, Other: Standard exercise programmeTreadmill training + cognitive tasks + standard exercise programme |
| Single task | Active comparator | Other: Treadmill Training, Other: Standard exercise programmeTreadmill training + standard exercise programme |
| Control | Active comparator | Other: Standard exercise programmeStandard exercise programme |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients with Idiopathic Parkinson Disease on medication who has
- Hoehn-Yahr 1-3
- Mini Mental Test score 20 and above
- Functional Ambulation Category 2 and above
- No changes in medication in last 3 months
Key exclusion criteria (7 listed)
- Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
- Global aphasia
- Severe cognitive dysfunction
- Other neurologic/orthopedic diseases
- Limiting cardiovascular or pulmonary disease
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 |
|---|---|---|
| Dual taskThe patients in the dual task group received cognitive tasks during treadmill training sessions. | Other | Dual task |
| Treadmill TrainingStandard treadmill training | Other | Dual task, Single task |
| Standard exercise programmeStandard exercise programme for Parkinson Disease | Other | Control, Dual task, Single task |
Primary outcome
10MWT
Time frame: 12 weeks
10 Meter Walk Test on comfortable speed
10MWT with cognitive tasks
Time frame: 12 weeks
10 Meter Walk Test with cognitive tasks
MoCA
Time frame: 12 weeks
Montreal Cognitive Assessment
TUG
Time frame: 12 weeks
Timed Up and Go Test
5 secondary outcomes
PDQ-39
Time frame: 12 weeks
FES-I
Time frame: 12 weeks
Stroop Test
Time frame: 12 weeks
FOGQ
Time frame: 12 weeks
Falls Diary
Time frame: 4 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 5 Apr 2019.
- Individual participant dataSharing planned: No
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Parkinson Disease
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.
Ayse Yaliman, Prof study director
Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
Ekin Ilke Sen, MD study director
Istanbul University Istanbul Faculty of Medicine Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task, Treadmill Training and Standard exercise programme in people with Parkinson Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 5 Apr 2019. 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 Turkey (Türkiye). 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?
10MWT (time frame: 12 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?
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 5 Apr 2019.