NCT06893120

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

March 18, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Biopsychosocial modeldepressiondisease managementexerciseParkinsons' Diseasequality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three months

Secondary Outcomes (7)

  • Beck Depression Scale (BECK-D)

    Three months

  • International physical activity questionnaire-Short (IPAQ-Short)

    Three months

  • Berg Balance Scale (BBS)

    Three months

  • 8-Item Parkinson's Disease Questionnaire (PDQ-8)

    Three months

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    Three months

  • +2 more secondary outcomes

Study Arms (2)

BETY session group

EXPERIMENTAL

Parkinson's Disease participating in BETY sessions.

Other: BETY

Control Group

NO INTERVENTION

Control groups continued their disease management under the follow-up of their neurologists.

Interventions

BETYOTHER

The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week.

BETY session group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with idiopathic Parkinson's disease
  • between 1-3 at home according to Modified Hoehn and Yahr Staging (MH\&Y)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alaaddin Keykubat University

Antalya, Alanya, 07425, Turkey (Türkiye)

Location

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseDepressionMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, PT, PhD(c)

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

September 7, 2022

Primary Completion

August 7, 2023

Study Completion

August 31, 2023

Last Updated

March 25, 2025

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Will not be shared to protect the data of individuals

Locations