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

NCT ID: NCT02435043

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2020-01-31

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Nature based rehabilitation

ten weeks of nature-based rehabilitation, as add-on to standard management

Group Type EXPERIMENTAL

Nature based rehabilitation

Intervention Type OTHER

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.

Treatment as usual

standard management after stroke

Group Type ACTIVE_COMPARATOR

standard management after stroke

Intervention Type OTHER

standard management after stroke is individualised.

Interventions

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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.

Intervention Type OTHER

standard management after stroke

standard management after stroke is individualised.

Intervention Type OTHER

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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role collaborator

Epidemiology and Register Centre South

UNKNOWN

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène Pessah-Rasmussen, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Locations

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Skåne university hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2012/352

Identifier Type: -

Identifier Source: org_study_id

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