A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)

Conditions
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Stroke

Intervention / Treatment
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* Other: Nature based rehabilitation
* Other: standard management after stroke


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nature based rehabilitation<br>ten weeks of nature-based rehabilitation, as add-on to standard management | Other: Nature based rehabilitation<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>standard management after stroke | Other: standard management after stroke<br>* standard management after stroke is individualised.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |