Does Cardiorespiratory Interval Training Improve Post-stroke Fatigue
Does a Cardiorespiratory Interval Training Program at Home Improve Post-stroke Fatigue?
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2018
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMay 13, 2024
May 1, 2024
6.7 years
March 2, 2018
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-stroke fatigue
Post-stroke fatigue will be measured with The Swedish Fatigue Assessment Scale (S-FAS) comprises 10 questions that describe how a person generally feels. The answers are given using a 5-point scale ranging from 1 (never) to 5 (always) such that the total score ranges from 10 to 50 points. Items 4 and 10 require reversed scoring. A high score indicate an increase level of fatigue.
The S-FAS will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test)
Secondary Outcomes (4)
Cardiorespiratory fitness (Peak oxygen consumption, VO2peak)
Cardiorespiratory fitness (peak oxygen consumption) will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test)
Feasibility (Fidelity)
Fidelity will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Feasibility (Adherence)
Adherence will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Feasibility (Adverse events)
Adverse events will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Study Arms (2)
Cardiorespiratory interval training
EXPERIMENTALCardiorespiratory interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks.
Usual care
NO INTERVENTIONUsual 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.
Interventions
A structured cardiorespiratory interval training program on an ergometer cycle 3 days a week for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with severe stroke with modified Rankin Scale \>3
- Atrial fibrillation, pacemaker or other arrhythmia which exclude reliable monitoring of heart-frequency
- Unstable pulmonary or cardiac disease
- Serious co-morbidity with for example terminal cancer, hemodialysis, severe cognitive dysfunction with Montreal Cognitive Assessment (MOCA) ≤ 26
- Drug abuse
- Patients living far away from the hospital or in residential care facilities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- Region Västerbottencollaborator
Study Sites (1)
Anna Bråndal
Umeå, s-90185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Bråndal, PhD
Department of Community Medicine and Rehabilitation, Physotherapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 2, 2018
First Posted
March 8, 2018
Study Start
March 19, 2018
Primary Completion
December 1, 2024
Study Completion
March 1, 2025
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share