Parkinson DiseaseNCT06893120
Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease
A study testing BETY in people with Parkinson Disease, run by Orkun Tüfekçi at 2 sites in Turkey (Türkiye).
Trial summary
Considering the impact of motor and non-motor findings on movement problems in the disease management of people living with PD, biopsychosocial evaluation and treatment approaches are essential. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BETY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Sep 2022to 31 Aug 2023
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic Parkinson's disease
- between 1-3 at home according to Modified Hoehn and Yahr Staging (MH\&Y)
Who cannot join
- Individuals who were diagnosed with dementia before Parkinson's diagnosis
- Had undergone deep brain stimulation
- Diagnosed with psychiatric or additional neurological diseases
- Had limited physical activity due to orthopedic problems or previous neurological diseases
- Had communication problems
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University
Ankara, Altındağ, 06100
Alaaddin Keykubat University
Antalya, Alanya, 07425
About this study
Official title: Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease
Considering the impact of motor and non-motor findings on movement problems in the disease management of people living with PD, biopsychosocial evaluation and treatment approaches are essential. However, there are not many studies investigating the impact of a biopsychosocial-based exercise approach on the biopsychosocial characteristics of individuals in PD management.
The Cognitive Exercise Therapy Approach (BETY), an innovative exercise approach based on the biopsychosocial model, has been developed with the participation of individuals with rheumatism in exercise sessions for many years. This study investigated the effects of the BETY, a supervised biopsychosocial model-based exercise intervention, on cognitive status, physical activity, balance, and biopsychosocial status in people living with PD.
- Conditions
- Parkinson Disease
- Being tested
- BETY
- Keywords
- Biopsychosocial model, depression, disease management, exercise, Parkinsons' Disease, quality of life
- Medical subject headings
- Parkinson Disease, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETYOther
The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week.
| Study group | Role | What they receive |
|---|---|---|
| BETY session group | Experimental | Parkinson's Disease participating in BETY sessions. Receives: Other: BETY |
| Control Group | No intervention | Control groups continued their disease management under the follow-up of their neurologists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire
Each question of the BETY-BQ consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status.
Measured: Three months
Secondary outcomes (7)
Beck Depression Scale (BECK-D)
It assesses the depression status of individuals. It consists of a total of 21 items assessing unhappiness, self-blame, self-dislike, thoughts of failure, irritability, crying, social withdrawal, indecision, fatigue, insomnia, loss of appetite, somatic distractions, and decreased libido. 1-10: Normal, 11-16: Mild mood changes, 17-20: Borderline clinical depression, 21-30: Moderate depression, 31-40: Severe depression, 40: Very severe depression
Measured: Three months
International physical activity questionnaire-Short (IPAQ-Short)
The scale includes questions about physical activity lasting at least 10 minutes or more in the last 1 week. The IPAQ-Short uses the Metabolic Equivalent (MET) method for physical activity level. Fixed MET values were determined for each section of the scale. These MET values are: Vigorous physical activity, 8 METs; moderate physical activity, 4 METs; walking, 3.3 METs; sitting, 1.5 METs. These MET values are multiplied by the time spent and the number of days, and the results for each activity are summed, and the total MET value is found. Total score values are in MET-minutes/week: Low-level physical activity - Total score < 600 MET min/week, Moderate physical activity - 3000 MET min/week > Total score ≥ 600 MET min/week, High-level physical activity - Total score ≥ 3000 MET min/week.
Measured: Three months
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) assesses the risk of falling in 14 situations that individuals may encounter daily. Each item is scored between 0-4 in this test according to the individual's ability. While a score of 4 indicates that the individual can complete that item, the highest score can be 56 points.0-20: High fall risk, 21-40: Moderate fall risk, 41-56: Low risk
Measured: Three months
8-Item Parkinson's Disease Questionnaire (PDQ-8)
The 8-item Parkinson's Disease Questionnaire (PDQ-8) consists of one item from each of the eight domains of the PDQ-39 (mobility, activities of daily living, emotional well-being, stigma, communication, social support, cognition, and physical discomfort) with the highest item-total correlation. Each question is scored between 0-4, with a total score in the range of 0-32. A higher score indicates a worse quality of life.
Measured: Three months
Unified Parkinson's Disease Rating Scale (UPDRS)
The scale consists of four parts: 1. Mental, behavioral, and mental status (4 questions), 2. Activities of daily living (13 questions), 3. Motor performance (14 questions), 4. Treatment complications (11 questions). It is used to assess motor impairment and disability in Parkinson's disease. The total score of the scale indicates the severity of the disease. A higher score indicates more severe Parkinson's disease.
Measured: Three months
Montreal Cognitive Assesment: MoCA
The Montreal Cognitive Assessment Test (MoCA) is an assessment tool developed to evaluate mild cognitive impairment. MoCA has items that test executive tasks such as abstract thinking, tracing tests, cube copying, clock drawing, similarity, naming, memory and attention, sentence repetition, verbal fluency, delayed recall, and orientation. This test is scored between 0-30. Cognitive status is considered normal above a total score of 21.
Measured: Three months
Modified Hoehn & Yahr Staging Scale (MH&Y)
It is used to determine the degree of disease and symptoms of Parkinson's disease. The scale has a seven-item staging system.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start7 Sep 2022
- Primary completion7 Aug 2023
- Study completion31 Aug 2023
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orkun Tüfekçi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893120
- Sponsor's protocol ID
- 07-06
- Status last verified
- Sep 2022
- First submitted
- 18 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06893120
- Acronym / sponsor ID
- 07-06
- Conditions
- Parkinson Disease
- Keywords
- Biopsychosocial model, depression, disease management, exercise, Parkinsons' Disease, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orkun TüfekçiUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Mar 2025 (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.
Considering the impact of motor and non-motor findings on movement problems in the disease management of people living with PD, biopsychosocial evaluation and treatment approaches are essential. However, there are not many studies investigating the impact of a biopsychosocial-based exercise approach on the biopsychosocial characteristics of individuals in PD management.
The Cognitive Exercise Therapy Approach (BETY), an innovative exercise approach based on the biopsychosocial model, has been developed with the participation of individuals with rheumatism in exercise sessions for many years. This study investigated the effects of the BETY, a supervised biopsychosocial model-based exercise intervention, on cognitive status, physical activity, balance, and biopsychosocial status in people living with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BETY session group | Experimental | Other: BETYParkinson's Disease participating in BETY sessions. |
| Control Group | No intervention | –Control groups continued their disease management under the follow-up of their neurologists. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with idiopathic Parkinson's disease
- between 1-3 at home according to Modified Hoehn and Yahr Staging (MH\&Y)
Key exclusion criteria (5 listed)
- Individuals who were diagnosed with dementia before Parkinson's diagnosis
- Had undergone deep brain stimulation
- Diagnosed with psychiatric or additional neurological diseases
- Had limited physical activity due to orthopedic problems or previous neurological diseases
- Had communication 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 |
|---|---|---|
| BETYThe cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week. | Other | BETY session group |
Primary outcome
BETY-Biopsychosocial Questionnaire
Time frame: Three months
Each question of the BETY-BQ consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status.
7 secondary outcomes
Beck Depression Scale (BECK-D)
Time frame: Three months
International physical activity questionnaire-Short (IPAQ-Short)
Time frame: Three months
Berg Balance Scale (BBS)
Time frame: Three months
8-Item Parkinson's Disease Questionnaire (PDQ-8)
Time frame: Three months
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Three months
Montreal Cognitive Assesment: MoCA
Time frame: Three months
Modified Hoehn & Yahr Staging Scale (MH&Y)
Time frame: Three months
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 25 Mar 2025.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETY in people with Parkinson Disease, run by Orkun Tüfekçi at 2 sites 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 2 inclusion and 5 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
BETY-Biopsychosocial Questionnaire (time frame: Three months). 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 25 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.