This study was conducted as single blinded two-armed randomised controlled trial (Clinical Trials.gov Identifier: NCT02435043). Patients were enrolled between February 2013 and August 2014. Blinded evaluation, by an occupational therapist (OT), was conducted 8 and 14 months after randomisation. The last follow-up was completed in November 2015.
We asked patients who had suffered from a stroke, living in the catchment area of the Skåne University Hospital, 50–80-years-old, independent in personal-ADL, reporting post stroke fatigue to participate in the study. Patients with dementia, severe aphasia, not fluent in Swedish and/or with severe comorbidities were excluded. The participants were included between February 2013 and August 2014. Patients in the sub-acute group were identified through a routine 3-month follow-up visit, while the chronic group was identified through review of medical records of all patients who had had a stroke during 2011. A nurse specialising in stroke interviewed all potential participants by phone (first assessment for eligibility) and performed a more detailed screening assessment by telephone or face-to-face (second assessment for eligibility) of the individuals who preliminarily matched the study criteria. The final assessment for eligibility was performed by a physician specialised in stroke (last author and PI: H.P-R). All participants provided a written informed consent.
The baseline examination, including the National Institute of Health Stroke Scale (NIHSS) score (16), Montreal Cognitive Assessment (MoCA) (17) and all outcome measurements were performed by H.P-R and an OT
After baseline evaluation, the patients were randomised into control, respective, intervention group by using opaque envelopes. The computational preparation of the adapted block randomisation lists was performed by using the SPSS Software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp). The sub-acute group, respectively, chronic-group were separately randomised.
Patients randomised to the intervention underwent a 10-week long NBR programme in groups of up to eight patients at Alnarp Rehabilitation Garden. The programme started within two weeks after randomisation and was scheduled for two days a week, with each day’s session lasting for three and a half hours. The NBR programme was grounded in horticultural therapy supported by a multimodal rehabilitation team that utilised the garden/nature for multi-sensory stimulation for physical, emotional and cognitive stimulation (13). The 2 hectare size garden contains places for work as well as rest and contemplation (doing and being), and is divided into two major areas: The Nature Area (informal and non-cultivated) and The Cultivation and Gardening Area (formal and cultivated). It is further subdivided into different garden rooms, each designed with special properties for supporting restorative activities or facilitates meaningful horticulture and garden activities (15).
Follow-up assessments 8 and 14 months after randomisation
All follow-ups were performed by a single OT with a very long-standing experience in stroke care and assessment. The OT was blinded to the allocation of the participants.
The primary outcomes in the study were the total score of post-stroke fatigue measured with Mental Fatigue Scale, (MFS) and the total scores for each dimension of perceived value of everyday occupations (Oval-pd) eight months after randomisation. The secondary outcomes were post-stroke fatigue and perceived value of every day occupation 14 months after randomisation and disability (mRS), anxiety (HAD), depression (HAD) and health related quality of life (EQ-5D) and 8 and 14 months after randomisation.
MFS (17, 18) is a 15-item self-assessment multidimensional questionnaire developed to measure mental fatigue in individuals with neurological disorders such as stroke and traumatic brain injury. The questionnaire has 15 items that concern issues such as fatigue in general, sensitivity to stress, sleeping disorders, concentration difficulties, sensitivity to sensory stimuli (e.g. sound, smell). Ratings of each item described are based on duration, frequency and intensity and can vary between 0 and 3 (0=normal function; 3=maximal symptom). A total score is calculated. Healthy population is reported to score a total score of < 5, where as a MFS score above 10 is indication of mental fatigue (19).
Oval-pd measures perceived values of everyday occupations (20). This self-assessment instrument consists of 26 statements on perceived value of everyday occupation, which the participant has performed during the last month. For each statement, five response alternatives are given: not at all, rather seldom, rather often and very often. The instrument is composed of three core dimensions: concrete, symbolic and self-reward value and has high validity and reliability (20). The total scores for each dimension are calculated.
The modified Rankin Scale (mRS) measures the degree of disability or dependence and is the most widely used clinical outcome measure in randomised clinical stroke trials (21). The scale runs from 0-6, from absence of symptoms to death. Disability is rated: 1 no significant, 2 slight, 3 moderate, 4 moderately severe and 5 severe.
EQ-5D 3L is a generic and widely used questionnaire on health related quality of life consisting on five questions covering: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Three response alternatives are provided: no problem, minor problem and total problem. Based on the categorical answers, a 5-digit number is settled and a total score is received, by using a tariff (22). The total score can have values between – 0.59 and 1.0, where 1.0 corresponds to full health. We used the UK-tariff (223).
Hospital Anxiety and Depression Scale (HAD) is a widely used screening questionnaire on depression and anxiety. A score (0–21) for depression and anxiety is calculated respectively. The different values are grouped into categories as follows: 0–7 no depression/anxiety; 8–10 risk for depression/anxiety and ≥ 11 possible depressions/anxiety (24).
No power calculations were carried out due to lack of reliable data for calculations. Instead, the study was limited by the period of funding.
Outcome variables were analysed according to the intention to treat principle, i.e. all randomised and correctly included patients were included in the statistical analysis. All variables were summarised, including mean/median values and min and max. The change of the outcomes was compared between the groups using the Wilcoxon rank sum test and within the groups using the Wilcoxon signed rank test. Missing data were not imputed. Results were considered statistically significant when p < 0.05.