StrokeNASTRUNCT02435043
A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
A study testing Nature based rehabilitation and standard management after stroke in people with Stroke, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Nature based rehabilitation and standard management after stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Nature based rehabilitation, standard management after stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature based rehabilitationOther
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 strokeOther
standard management after stroke is individualised.
| Study group | Role | What they receive |
|---|---|---|
| Nature based rehabilitation | Experimental | ten weeks of nature-based rehabilitation, as add-on to standard management Receives: Other: Nature based rehabilitation |
| Treatment as usual | Active comparator | standard management after stroke Receives: Other: standard management after stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post stroke fatigue
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
Measured: 8 months after inclusion
Occupational value of everyday occupation
Occupational Value (OVal-pd) pre-post design by blinded assessor
Measured: 8 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startAug 2012
- Primary completionMay 2015
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Swedish University of Agricultural Sciences, Epidemiology and Register Centre South
- Responsible party
- Sponsor
- Investigators
- Hélène Pessah-Rasmussen, MD, Ph.D., Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435043
- Sponsor's protocol ID
- 2012/352
- Acronym
- NASTRU
- Status last verified
- Feb 2020
- First submitted
- 7 Apr 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
- ClinicalTrials.gov ID
- NCT02435043
- Acronym / sponsor ID
- NASTRU / 2012/352
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Swedish University of Agricultural Sciences, Epidemiology and Register Centre South
- Study start
- Aug 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature based rehabilitation | Experimental | Other: Nature based rehabilitationten weeks of nature-based rehabilitation, as add-on to standard management |
| Treatment as usual | Active comparator | Other: standard management after strokestandard management after stroke |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Dementia
- Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature based rehabilitationten 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. | Other | Nature based rehabilitation |
| standard management after strokestandard management after stroke is individualised. | Other | Treatment as usual |
Primary outcome
Post stroke fatigue
Time frame: 8 months after inclusion
Mental Fatigue Scale (MFS) pre-post design by blinded assessor.
Occupational value of everyday occupation
Time frame: 8 months after inclusion
Occupational Value (OVal-pd) pre-post design by blinded assessor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Pessah-Rasmussen, MD, Ph.D. principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature based rehabilitation and standard management after stroke in people with Stroke, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post stroke fatigue (time frame: 8 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.