Does a Cardiorespiratory Interval Training Program at Home Improve Post-stroke Fatigue?

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Preliminary or final diagnosis of acute stroke due to Brain infarction: large vessel disease, lacunar syndrome, cryptogenic stroke Intracerebral hemorrhage

• Post-stroke fatigue (defined as a summation score of 28 or more on the S-FAS)

• Medical stability

• Independent living in Umeå or Gävle (in the nearby surrounding areas) and able to cycle an ergometer cycle.

Locations
Other Locations
Sweden
Anna Bråndal
RECRUITING
Umeå
Contact Information
Primary
Anna Bråndal, PhD
anna.brandal@umu.se
+46702197609
Backup
Per Wester, MD, PhD
per.wester@umu.se
+46703280001
Time Frame
Start Date: 2018-03-19
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 50
Treatments
Experimental: Cardiorespiratory interval training
Cardiorespiratory interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks.
No_intervention: Usual care
Usual ESD care including information about post-stroke fatigue, support and practical advice about how to identify and manage fatigue symptoms in daily tasks, such as the adaptation and prioritization of activities, physical activity and rest.
Related Therapeutic Areas
Sponsors
Leads: Umeå University
Collaborators: Region Västerbotten

This content was sourced from clinicaltrials.gov