Physical Activity in Persons With Parkinson's Disease

NCT06901869 | Recruiting

• 2 other identifiers: 2024-07526-012024-06332
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Physical Inactivity

Outcome Measures

Primary Outcomes (5)

• Feasibility of the assessment battery - length of the clinical examination and questionnaires

  The pilot/feasibility study aims to evaluate feasibility of the assessment battery measured the time it takes to complete the examination and questionnaires.

  Baseline

• Feasibility of the assessment battery - perception of the clinical examination

  Feasibility of the assessment battery will also be evaluated through semi-structured questions regarding fatique, concentration, pain/discomfort to the participants after the clinical examination.

  Baseline

• Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap

  Compliance will be measured with percentages of completed questionnaires in REDCap.

  Baselline

• Feasibility of the assessment battery - Suitability of the primary outcome

  Suitability of the accelerometers in the home environment as the primary outcome for the targeted patient group will be assessed by the percentage of participants that are able to wear the accelerometer for at least 4 days days and render valid data.

  Baseline

• Physical activity levels

  The ActiGraph accelerometer (GT3X+, ActiGraph, Pensacola, FL, US) will be used to measure absolute and relative time spent in sedentary behavior, low intensity physical activity (LIPA) and moderate to vigorous intensity physical activity (MVPA), by total time in bouts.

  Baseline

Secondary Outcomes (20)

• Physical activity - self rated

  Baseline

• Disease severity, Parkinson symptoms

  Baseline

• Gait

  Baseline

• Balance performance

  Baseline

• Anxiety and depression

  Baseline

Other Outcomes (2)

• Working och long-term memory

  Baseline

• Parkinson related pain

  Baseline

Study Arms (1)

People with Parkinson's disease

No intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Karolinska Institutet: lead
• Lund University: collaborator
• Göteborg University: collaborator
• Umeå University: collaborator
• Region Stockholm: collaborator
• Vastra Gotaland Region: collaborator
• Region Skane: collaborator
• Region Västerbotten: collaborator

Study Sites (1)

Karolinska institutet

Stockholm, Solna, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Sedentary Behavior

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Erika Franzén

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Compliance Office Karolinska Insitutet

CONTACT

+46852480000; compliance@ki.se

Erika Franzén

CONTACT

+46852488878; erika.franzen@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 30, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The investigators plan to share this when applicable on OSF or similar
• Access Criteria: The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.

Locations

SE (1)