Actively Recruiting
Does Cardiorespiratory Interval Training Improve Post-stroke Fatigue
Led by Umeå University · Updated on 2024-05-13
50
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Post-stroke fatigue is common and negatively influences post-stroke recovery. Today, there is insufficient evidence how to treatment post-stroke fatigue. Our objective is to investigate if a structured cardiorespiratory interval training program added to the early supported discharge (ESD)-service results in relieved post-stroke fatigue and increased oxygen uptake. This is a 1:1 prospective randomized open- label trial(Two-centre study) with blinded evaluators (PROBE-design) of 50 participants referred to ESD with study start at 4 (±1) weeks after discharge from the stroke unit. The intervention group (N=25) receives a structured cardiorespiratory interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks. The cardiorespiratory interval training program comprises of 4x4 minute interval, at 70 to 80% of peak heart rate, interrupted by 3 minutes active recovery. The control group (N=25) receives usual ESD care. The primary outcome will be a shift in the Swedish Fatigue Assessment Scale before intervention (baseline) versus 8 weeks months after start of intervention in the intervention and control groups. Secondary outcomes include cardiorespiratory fitness, compliance, adherence and adverse events.
CONDITIONS
Official Title
Does Cardiorespiratory Interval Training Improve Post-stroke Fatigue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preliminary or final diagnosis of acute stroke due to brain infarction (large vessel disease, lacunar syndrome, cryptogenic stroke) or intracerebral hemorrhage
- Post-stroke fatigue with a score of 28 or more on the Swedish Fatigue Assessment Scale
- Medically stable
- Living independently in or near Umeå or Gävle and able to use an ergometer cycle
You will not qualify if you...
- Severe stroke with modified Rankin Scale greater than 3
- Atrial fibrillation, pacemaker, or arrhythmia preventing reliable heart rate monitoring
- Unstable lung or heart disease
- Serious other illnesses such as terminal cancer or hemodialysis
- Severe cognitive dysfunction with Montreal Cognitive Assessment score 26 or lower
- Drug abuse
- Living far from the hospital or in residential care facilities
AI-Screening
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Trial Site Locations
Total: 1 location
1
Anna Bråndal
Umeå, Sweden, s-90185
Actively Recruiting
Research Team
A
Anna Bråndal, PhD
CONTACT
P
Per Wester, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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