A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
NASTRU
A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
1 other identifier
interventional
101
1 country
1
Brief Summary
The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFebruary 13, 2020
February 1, 2020
2.7 years
April 7, 2015
February 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Post stroke fatigue
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
8 months after inclusion
Occupational value of everyday occupation
Occupational Value (OVal-pd) pre-post design by blinded assessor
8 months after inclusion
Study Arms (2)
Nature based rehabilitation
EXPERIMENTALten weeks of nature-based rehabilitation, as add-on to standard management
Treatment as usual
ACTIVE COMPARATORstandard management after stroke
Interventions
ten weeks of nature-based rehabilitation, as add-on to standard management. A rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention was grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilized the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.
standard management after stroke is individualised.
Eligibility Criteria
You may qualify if:
- Ischemic or haemorrhagic stroke
- First ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2)
- Age: 55-80 years
You may not qualify if:
- Dementia
- Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
- Swedish University of Agricultural Sciencescollaborator
- Epidemiology and Register Centre Southcollaborator
Study Sites (1)
Skåne university hospital
Malmo, 205 02, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène Pessah-Rasmussen, MD, Ph.D.
Skane University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2015
First Posted
May 6, 2015
Study Start
August 1, 2012
Primary Completion
May 1, 2015
Study Completion
January 1, 2020
Last Updated
February 13, 2020
Record last verified: 2020-02