Clinical trial NCT04314388: Stroke in Young Adults Outdoor Rehabilitation
Official title: Stroke in Young Adults: The Influence of An Outdoor Walking Rehabilitation Programme on Walking Performance and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Stroke Rehabilitation
Outdoor Walking
Walking Performance
Young Adults
Quality of life
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: Brecon Beacons National Park Authority
First posted: 2020-03-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to two groups using blocked randomisation (stratified by site).
Primary purpose: OTHER

Brief summary: This research project aims to improve and promote physical activity participation in the outdoors and use outdoor walking as a form of long-term rehabilitation for young adults who have had a stroke.

This research is specifically focused on adults of working age (e.g. 18 to 65 years classed as young adults) as there is little to no research or rehabilitation programmes for young adults who have had a stroke on how best to regain function and independence to return to social/leisure activities, employment and education. During this study, The investigators will measure how fast a young adult who has had a stroke walks, how much energy they use to walk and how their joints move when walking. The investigators will also use questionnaires to measure how confident a young adult who has had a stroke is and how they feel when outdoors.

This project could highlight the positive role of exercising in outdoor natural environments to promote recovery following stroke in young adults. The investigators predict that an outdoor-walking rehabilitation programme could motivate the young stroke population to better engage in their rehabilitation, as walking in more challenging environments could facilitate an increase in the desire to walk outdoors and confidence.

Detailed description: This study is a randomised controlled trial, which will investigate whether an outdoor-walking rehabilitation programme can improve walking performance (how efficiently and how fast or slow an individual is able to walk) and quality of life of young adults who have had a stroke, compared to controls who have had a stroke, who will not be provided with the outdoor-walking programme. Forty-six individuals aged between 18 and 65 years, who have had a stroke in the last three years, will be recruited to participate in this study. Participants will be recruited from 3 health boards in Wales, United Kingdom: Aneurin Bevan University Health Board, Swansea Bay University Health Board and Cwm Taf University Health Board.

For the development of the outdoor-walking rehabilitation programme, the Consensus for Exercise Reporting Template (CERT) was followed. The outdoor-walking rehabilitation programme will run over 3 months and take place in Wales, United Kingdom. Each week will include once-per-week, outdoor-walking instructor-led sessions. The walking routes planned for the rehabilitation programme will be detailed in an exercise diary provided to the participant. This will include information such as distance, terrain (e.g gravel, tarmac, grass), environment (e.g woodland, lowland, moorland), gradient (e.g uphill to downhill ratio, how steep/ flat) and perceived level of difficulty.

The primary outcome measures for this study are walking speed and quality of life. Secondary outcomes include metabolic cost and biomechanical function. Outcomes will be measured pre and post 3-month rehabilitation data collection. Walking speed and metabolic cost will be measured during a 3-minute walking protocol. Quality of life will be measured using the standardised Stroke Aphasia Quality of Life (SAQOL), Confidence after stroke measure (CaSM) and Nature-relatedness scale (NR). Participants will also be asked to provide three difficulties they have experienced post-stroke (e.g difficulty walking) and three aims (e.g to go back to work) .

Biomechanical function will involve analysing joint kinetic and kinematics and measured during the biomechanical function protocol. Adherence to the outdoor-walking rehabilitation programme will be measured pre, post-rehabilitation and follow-up through the use of the exercise diary and questionnaires.

The results from this project will be used as benchmark data to provide evidence to support the role of outdoor rehabilitation in natural outdoor environments and green spaces for promoting health and wellbeing of young adults who have had a stroke.

Eligibility criteria: Inclusion Criteria:

* Young adults who have had a stroke and capable of giving informed consent\*
* Aged 18-65 years
* Male or Female
* Stroke within the last 3 years
* Cause of stroke from cerebral infarct or haemorrhage that is clinically evident or from a Computerised Tomography Scan (CT Scan) or Magnetic Resonance Imaging (MRI) Scan
* Able to walk continuously for 5 minutes and have a walking speed between 0.6 and 0.9m/s. Walking speed will be ascertained by physiotherapists using the 10-metre walk test (10MWT).

  * If a participant has cognitive impairment we will rely on the expertise of the clinical team as to whether they have an adequate cognitive function to provide informed consent.

Exclusion Criteria:

* A patient diagnosed with a respiratory disease, musculoskeletal disease or injury or an auto-immune disease will be excluded from this study if this comorbidity is the predominant health concern or the major factor that limits their ability to walk.
* Amputation of more than one digit
* Unable to speak or comprehend English\*
* Unable to or unwilling to comprehend informed consent
* A patient is currently participating in another rehabilitation programme or study

  * Welsh translated versions of the participant information sheet, consent form and contact form will be provided to all participants. However, the participant must be able to understand spoken English as the data collection protocols will be explained in English by the researcher.

Primary outcomes:
measure: Change in walking speed
timeFrame: 5 months
measure: Change in quality of life
timeFrame: 5 months
measure: Change in confidence (sub-measure of quality of life)
timeFrame: 5 months
measure: Change in nature-relatedness: attitudes to natural outdoor environments (sub-measure of quality of life)
timeFrame: 5 months
measure: Change in aims and difficulties (sub-measure of quality of life)
timeFrame: 5 months
Secondary outcomes:
measure: Change in metabolic cost (efficiency)
timeFrame: 5 months
measure: Change in biomechanical function (gait analysis)
timeFrame: 5 months
measure: Adherence to the outdoor-walking rehabilitation programme
timeFrame: 5 months
Other outcomes:
Locations:
city: Llantrisant
country: United Kingdom
facility: Cwm Taf Morgannwg university Health Board
state: Rhondda Cynon Taff
city: Newport
country: United Kingdom
facility: Aneurin Bevan University Health Board
state: South Wales
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
state: South Wales
Study officials:
affiliation: Research Associate
name: Hannah Jarvis
role: PRINCIPAL_INVESTIGATOR
References: