Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT03458884

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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