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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435043
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Lund University
Swedish University of Agricultural Sciences
Epidemiology and Register Centre South
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Other: Nature based rehabilitation Other: standard management after stroke Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Study Start Date : August 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nature based rehabilitation
ten weeks of nature-based rehabilitation, as add-on to standard management
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.

Active Comparator: Treatment as usual
standard management after stroke
Other: standard management after stroke
standard management after stroke is individualised.




Primary Outcome Measures :
  1. Post stroke fatigue [ Time Frame: 8 months after inclusion ]
    Mental Fatigue Scale (MFS) pre-post design by blinded assessor.

  2. Occupational value of everyday occupation [ Time Frame: 8 months after inclusion ]
    Occupational Value (OVal-pd) pre-post design by blinded assessor



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435043


Locations
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Sweden
Skåne university hospital
Malmö, Sweden, 205 02
Sponsors and Collaborators
Region Skane
Lund University
Swedish University of Agricultural Sciences
Epidemiology and Register Centre South
Investigators
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Principal Investigator: Hélène Pessah-Rasmussen, MD, Ph.D. Skane University Hospital
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02435043    
Other Study ID Numbers: 2012/352
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms