A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Occupational value of everyday occupation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Arms & Interventions
Nature based rehabilitation
ten weeks of nature-based rehabilitation, as add-on to standard management
Intervention: Nature based rehabilitation (Other)
Treatment as usual
standard management after stroke
Intervention: standard management after stroke (Other)
Outcomes
Primary Outcomes
Occupational value of everyday occupation
Time Frame: 8 months after inclusion
Occupational Value (OVal-pd) pre-post design by blinded assessor
Post stroke fatigue
Time Frame: 8 months after inclusion
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
Secondary Outcomes
No secondary outcomes reported