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Completed

NCT Number: NCT02435043

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne university hospital

Malmö, 205 02, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nature based rehabilitation

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.

standard management after stroke

Other

standard management after stroke is individualised.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Epidemiology and Register Centre South
  • Lund University
  • Swedish University of Agricultural Sciences

Registry information

Official study title

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

Acronym: NASTRU

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
May 6, 2015
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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