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

Stroke Clinical Trial

— NASTRU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435043
• Other study ID #: 2012/352
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 2020
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Stroke

Intervention

Other:
• Nature based rehabilitation
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
standard management after stroke is individualised.

Locations

Country	Name	City	State
Sweden	Skåne university hospital	Malmö

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Epidemiology and Register Centre South, Lund University, Swedish University of Agricultural Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post stroke fatigue	Mental Fatigue Scale (MFS) pre-post design by blinded assessor.	8 months after inclusion
Primary	Occupational value of everyday occupation	Occupational Value (OVal-pd) pre-post design by blinded assessor	8 months after inclusion