More Steps Towards an Active Life - ActForStroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 50
- Locations
- 20
- Primary Endpoint
- Physical activity
Study Overview
Brief Summary
The main goal of this quasi-experimental study is to prevent the negative consequences of mobility impairments after stroke. These include recurrent strokes, general deconditioning, and overweight on the physical side, and dependency, isolation, caregiver strain, and reduced quality of life from a psycho-social perspective.
ActForStroke, a combination of high-intensity gait training and subsequent remote coaching and activity monitoring, will contribute to more steps, higher activity levels and increased participation. ActForStroke requires minimal extra resources and can easily be implemented within existing staffing levels.
The investigators want to examine if patients who participate in the ActForStroke intervention are more active one year after stroke.
Patients with stroke will either participate in a combined intervention of high-intensity gait training and subsequent coaching to facilitate physical and social activity or receive standard care.
Detailed Description
Stroke is worldwide the second most common cause of long-term disability. In Denmark, stroke affects around 12,000 people each year, and around 110,000 are living with the consequences of a stroke. One in five Danes over 25 will experience a stroke during their lifetime, and 30% of stroke victims are under 65 years old. These numbers imply not only a significant burden for the individual and their caregivers but also for society in general. The costs for treatment and care amount to 2.03 billion DKK annually, not including lost working capacity. People living with the consequences of a stroke are at a high risk of early death, recurrent strokes (around 10-26 % during the first years), and myocardial infarctions, aggravated by risk factors, such as diabetes and overweight, both from prior to stroke and after. A huge amount of evidence supports the preventive effect of physical activity in everybody, including those with stroke and comorbidities or other medical issues. To achieve a sufficient level of physical activity according to official recommendations (>30 min moderate activity per day plus 2 x 20 min vigorous activity per week) is challenging for almost everybody but can be especially challenging for people with stroke due to reduced mobility.
Gait after stroke Around two-thirds of those affected suffer from impaired gait function which limits their independence and participation in valued activities and compromises their physical fitness and psycho-social well-being. Recovery of walking early following neurologic injury is a primary goal of patients and their families. However, many walk at a slow pace and for limited distances. A majority of patients still suffer from reduced walking ability at discharge from the hospital. This can lead to a more homebound life with a reduction of social relations and a less active everyday life. Studies suggest that even small declines in gait speed from baseline (i.e., change of 0.1 m/s) are associated with significant increases in health care utilization (e.g., medical/surgical visits, hospitalization duration).
Inactivity after stroke is a consequence of walking impairment or just co-occurring with it, many people with stroke spend too much of their time sedentary and physically inactive. Studies indicate that people with stroke spend more time sedentary and in long uninterrupted sedentary bouts than age-matched healthy people. Interestingly, physical activity seems not to be directly related to their functional level. As inactivity is directly associated with increased cardiovascular risk, the risk for recurrent strokes increases.
ActForStroke With ActForStroke, the investigators want to address these challenges with the following combined interventions that are intended to start during inpatient rehabilitation and continue in municipality rehabilitation.
High-intensity gait training (HIGT) is based on substantial amounts of stepping practice at 70-85 % maximum heart rate. HIGT has been proven effective in other countries in enabling patients with stroke to achieve better gait and balance and, thus increasing their opportunities for an active and independent life. The effect could be maintained 1 year after stroke. Intensive gait training is now recommended by national guidelines for stroke rehabilitation in the US, UK, and Australia. HIGT is an approach that can be implemented within existing staffing levels and thus constitutes a viable long-term approach. However, it is usual practice in Denmark.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years
- •stroke within the last 6 months
- •able to give informed consent according to the neurorehabilitation team's evaluation and/or cognitive testing
- •receiving rehabilitation for post-stroke functional impairments.
Exclusion Criteria
- •Use of bracing or instrumentation (e.g. ventilator) that limits walking independence in walking outdoors and on stairs
- •Functional Ambulation Category (FAC) at admission = 5 (independent ambulator on all surfaces)
- •uncontrolled cardiopulmonary, metabolic, infectious or psychiatric disorders
- •any disorder that prevented walking > 50 meters prior to injury
Outcomes
Primary Outcomes
Physical activity
Time Frame: From baseline up to 12 months after stroke, 4 assessments will be conducted at inclusion to the study, 2 weeks after inclusion, 6 months and 12 months after stroke.
The main outcome measure will be the average number of non-sedentary minutes per day measured during 3 days of sensor measurements. The SENS motion® wearable sensor will be used to monitor physical activity during 3 days. The SENS motion® registers acceleration on x,y,z axes.
Secondary Outcomes
- 10m walk test(Two assessments: At inclusion to the study, 2 weeks after inclusion.)
- Timed-up-and-go(Two assessments: At inclusion to the study, 2 weeks after inclusion.)
- 6 minutes walk test(Two assessments: At inclusion to the study, 2 weeks after inclusion.)
- Sit-to-stand test(Two assessments: At inclusion to the study, 2 weeks after inclusion.)
- Five-level EQ5d (EQ5D) (there is no full name)(Four assessments up to 12 months after stroke: At inclusion, after two weeks, 6 months and 12 months after stroke.)
- Stroke Specific Quality of Life (SSQL)(6 and 12 months after stroke)
- Care giver burden scale(6 and 12 months after stroke)
- Intensity of physical activity(Four measurements up to 12 months after stroke, at inclusion, 2 weeks after inclusion, 6 and 12 months after stroke)
- Steps per day(Four assessments up to 12 months after stroke: At inclusion, after two weeks, 6 months and 12 months after stroke.)
