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Recruiting NCT06901869

Physical Activity in Persons With Parkinson's Disease

Observational Parkinson Disease Physical Inactivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease, Physical Inactivity. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study

Overview

Parkinson's disease (PD) is a leading neurodegenerative health condition in Sweden and a public health concern. Although no cure exists, functional independence and participation in society remain top priorities, and can be achieved through targeted physical activity (PA) interventions. To date, few longitudinal cohort studies have been conducted, using PA as main outcome in therapy research, partly due to the complex nature of predicting and controlling this phenomenon. To help address this knowledge gap, the overall purpose of the future long-term (ActivPARK) study is to enhance knowledge of the evolution of PA behavior, and how it is influenced beyond the disease characteristics using a broad explanatory model, in persons with PD from a diversity of settings in Sweden with the aim of prescribing tailored and personalized interventions to enhance functioning, health, and wellbeing throughout the disease progression and recommend potential health care pathway modifications. The investigators have just established an expert group, comprising researchers, healthcare professionals, and PD organisations (including persons with PD) and reached consensus on essential priority clinical therapy research questions on PA and methodological considerations. The next phase entails performing a multicentre feasibility/pilot study, further developing and refining the assessment battery and research questions linked to the improved explanatory model for PA and methodology, to inform the definite larger clinical cohort study.

Primary outcome measures

  • Feasibility of the assessment battery - length of the clinical examination and questionnaires [Time frame: Baseline]
  • Feasibility of the assessment battery - perception of the clinical examination [Time frame: Baseline]
  • Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap [Time frame: Baselline]
  • Feasibility of the assessment battery - Suitability of the primary outcome [Time frame: Baseline]
  • Physical activity levels [Time frame: Baseline]
Secondary outcome measures (12)
  • Physical activity - self rated [Time frame: Baseline]
  • Disease severity, Parkinson symptoms [Time frame: Baseline]
  • Gait [Time frame: Baseline]
  • Balance performance [Time frame: Baseline]
  • Anxiety and depression [Time frame: Baseline]
  • Cognitive performance [Time frame: Baseline and 3 year follow-up]
  • Self assessed cognitive function [Time frame: Baseline]
  • Non-Motor Symptoms [Time frame: Baseline]
  • Walking ability- self assessed [Time frame: Baseline]
  • Freezing of gait - self-assessed [Time frame: Baseline]
  • Balance confidence [Time frame: Baseline]
  • Motivation [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Diagnosed with Parkinson's disease
  • Mild to severe disease severity ( Hoehn \& Yahr 1-4).

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska institutet — Stockholm

Identifiers

NCT: NCT06901869 · 2024-07526-01 · 2024-06332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗