A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU) (NASTRU)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nature based rehabilitation
standard management after stroke
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion criteria:
- Dementia
- Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Sites / Locations
- Skåne university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nature based rehabilitation
Treatment as usual
Arm Description
ten weeks of nature-based rehabilitation, as add-on to standard management
standard management after stroke
Outcomes
Primary Outcome Measures
Post stroke fatigue
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
Occupational value of everyday occupation
Occupational Value (OVal-pd) pre-post design by blinded assessor
Secondary Outcome Measures
Full Information
NCT ID
NCT02435043
First Posted
April 7, 2015
Last Updated
February 12, 2020
Sponsor
Region Skane
Collaborators
Lund University, Swedish University of Agricultural Sciences, Epidemiology and Register Centre South
1. Study Identification
Unique Protocol Identification Number
NCT02435043
Brief Title
A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Acronym
NASTRU
Official Title
A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University, Swedish University of Agricultural Sciences, Epidemiology and Register Centre South
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.
The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014. Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. A parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nature based rehabilitation
Arm Type
Experimental
Arm Description
ten weeks of nature-based rehabilitation, as add-on to standard management
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
standard management after stroke
Intervention Type
Other
Intervention Name(s)
Nature based rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard management after stroke
Intervention Description
standard management after stroke is individualised.
Primary Outcome Measure Information:
Title
Post stroke fatigue
Description
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
Time Frame
8 months after inclusion
Title
Occupational value of everyday occupation
Description
Occupational Value (OVal-pd) pre-post design by blinded assessor
Time Frame
8 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion criteria:
Dementia
Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Pessah-Rasmussen, MD, Ph.D.
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne university hospital
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
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