Physical Activity in Persons With Parkinson's Disease (ActivPARK)
2026년 5월 13일 업데이트: Erika Franzén, Karolinska Institutet
Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study
This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences.
This is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.
연구 개요
상태
모병
연구 유형
관찰
등록 (추정된)
450
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Compliance Office Karolinska Insitutet
- 전화번호: +46852480000
- 이메일: compliance@ki.se
연구 연락처 백업
- 이름: Erika Franzén
- 전화번호: +46852488878
- 이메일: erika.franzen@ki.se
연구 장소
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Stockholm, 스웨덴
- 모병
- Karolinska University Hospital
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연락하다:
- Erika Franzén, PhD
- 전화번호: +46852488878
- 이메일: erika.franzen@ki.se
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연락하다:
- LIsa Sandberg, MSc
- 이메일: lisa.sandberg@ki.se
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
설명
Inclusion Criteria:
- People diagnosed with idiopathic Parkinson's disease
- Hoehn & Yahr 1 to 4
Exclusion Criteria:
- Hoehn & Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
- Unable to perform critical physical activity and clinical assessments
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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People with Parkinson´'s disease
No intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Physical activity - low and moderate intensity
기간: Baseline and yearly follow-ups for 3 years
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The primary outcome is changes over time in PA (i.e.
low + moderate-vigorous intensity PA in time spent per day) measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Physical activity - total vector magnitude
기간: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change over time in total vector magnitude measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - low intensity
기간: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in time spent in low intensity physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - moderate high intensity
기간: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in time spent in moderate-vigorous physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity- sedentary
기간: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in sedentary time per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - steps
기간: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in steps per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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인지 성능
기간: 기준선 및 3 년 후속 조치
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몬트리올인지 평가 (MOCA), 0-25, 높은 점수 = 더 나은 것으로 평가
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기준선 및 3 년 후속 조치
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Disease severity, Parkinsons symptoms
기간: Baseline and 3 year follow-up
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Disease severity measured with the Movement Disorders Society -Unified Parkinson's Disease Rating Scale) parts 1 to 4. Higher scores = worse/more symptoms |
Baseline and 3 year follow-up
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Gait
기간: Baseline and 3 year follow-up
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Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
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Baseline and 3 year follow-up
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Balance performance
기간: Baseline and 3 year follow-up
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Assessed with the Mini-BESTest.
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. 0-28 points with higher scores indicating better balance control
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Baseline and 3 year follow-up
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Anxiety and depression
기간: Baseline and yearly follow-ups for 3 years
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Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively.
Lower score=better
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Baseline and yearly follow-ups for 3 years
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Motivation
기간: Baseline and yearly follow-ups for 3 years
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Assessed with the Behavioural Regulation in Exercise Questionnaire (BREQ 4), a 28-item survey that measures exercise motivation.
The questionnaire uses a 7-point Likert scale, ranging from one to seven.
Maximum 196.
Higher scores = higher motivation
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Baseline and yearly follow-ups for 3 years
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Self-efficacy
기간: Baseline and yearly follow-ups for 3 years
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Assessed with the Self-efficacy and motivation for exercise/physical activity (ESES).
10 questions rated on a 4 point Likert scale.
Maximun 40 points, higher scores= better self-efficacy
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Baseline and yearly follow-ups for 3 years
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Physical activity history and preferences,
기간: Baseline
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Self-made questions on physical activity history and preferences
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Baseline
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Self assessed cognitive function
기간: Baseline and yearly follow-ups for 3 years
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Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse
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Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms
기간: Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer.
More yes answers = more non-motor symptoms
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Baseline and yearly follow-ups for 3 years
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Walking ability- self rated
기간: Baseline and yearly follow-ups for 3 years
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WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
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Baseline and yearly follow-ups for 3 years
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Freezing of gait - self-assessed
기간: Baseline and 3 year follow-up
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Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
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Baseline and 3 year follow-up
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Balance confidence
기간: Baseline and yearly follow-ups for 3 years
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Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
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Baseline and yearly follow-ups for 3 years
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Fatigue
기간: Baseline and yearly follow-ups for 3 years
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Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree .
more points/score= worse.
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Baseline and yearly follow-ups for 3 years
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Disability
기간: Baseline and 3 year follow-up
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World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
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Baseline and 3 year follow-up
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Sleep
기간: Baseline and 3 year follow-up
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Scales for Outcomes in Parkinson's disease - Sleep (SCOPA-SLEEP), 4 parts, A-2 questions, B-5 questions , C-1 question and D- 6 questions.
Higher= worse
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Baseline and 3 year follow-up
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Self-rated pain
기간: Baseline and yearly follow-ups for 3 years
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Assessed with visual analog scale, VAS from 0 to 100
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Baseline and yearly follow-ups for 3 years
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Health related quality of life
기간: Baseline and yearly follow-ups for 3 years
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Parkinson's Disease Questionnaire (PDQ39).
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communications and bodily discomfort).
The sum score is as a percentage score ranging between 0 and 100.
Higher is better
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Baseline and yearly follow-ups for 3 years
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Wellbeing
기간: Baseline and yearly follow-ups for 3 years
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The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
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Baseline and yearly follow-ups for 3 years
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Nutrition
기간: Baseline and 3 year follow-up
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Mini Nutritional Assessment, max 14. higher = better
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Baseline and 3 year follow-up
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Socioeconomic status
기간: Baseline
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Education and income level.
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Baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Erika Franzén, Karolinska Institutet
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 15일
기본 완료 (추정된)
2030년 12월 31일
연구 완료 (추정된)
2031년 1월 30일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 7일
처음 게시됨 (실제)
2026년 5월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 13일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 4-438/2024
- 2024-07526-01 (기타 식별자: Swedish Ethical Review Authority)
- 06901869 (기타 식별자: Clinical Trials registration -pilot study)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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, provided that the recipient has an approved ethics application.
IPD 공유 기간
We plan to share this when applicable on OSF or similar
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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