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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: standard management after stroke; Other: Nature based rehabilitation

• Registration Number: NCT02435043
• Lead Sponsor: Region Skane

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-30
• Primary Completion: 2015-05
• Study First Posted: 2015-05-06
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	standard management after stroke	standard management after stroke
Nature based rehabilitation	Nature based rehabilitation	ten weeks of nature-based rehabilitation, as add-on to standard management

Primary Outcome Measures

Name	Time	Method
Occupational value of everyday occupation	8 months after inclusion	Occupational Value (OVal-pd) pre-post design by blinded assessor
Post stroke fatigue	8 months after inclusion	Mental Fatigue Scale (MFS) pre-post design by blinded assessor.

Trial Locations

Locations (1)

Skåne university hospital; 🇸🇪 Malmö, Sweden