Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03458884 |
Other study ID # |
2015-420-31M |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 19, 2018 |
Est. completion date |
March 1, 2025 |
Study information
Verified date |
May 2024 |
Source |
Umeå University |
Contact |
Anna Bråndal, PhD |
Phone |
+46702197609 |
Email |
anna.brandal[@]umu.se |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Stroke is a major cause of disability among adults. After stroke, post-stroke fatigue is a
common and negatively influences post-stroke recovery. Today, there is insufficient evidence
how to treatment post-stroke fatigue. Post-stroke fatigue is considered to have a
multifactorial cause and it is biologically plausible that fatigue might be related to
physical deconditioning and reduced physical activity.
After stroke, functional limitations often lead to a reduction in physical activity, which in
turn may lead to decline in cardiorespiratory fitness. Cardiorespiratory fitness is often
measured as peak oxygen consumption, VO2peak. Studies have reported that physical activity
and cardiorespiratory fitness is lower in stroke victims than gender- and aged-matched
healthy individuals.
Intervention aimed to increased cardiorespiratory fitness has been highlighted as an
important component in in stroke rehabilitation. Guidelines for physical activity and
cardiorespiratory fitness following stroke recommend cardiorespiratory training 20-60
minutes, 3-7 days a week at 50-80% of maximal heart rate. Interval training (4 x 4 minutes)
has showed to improve cardiovascular fitness at different patient groups, including Stroke.
Today, stroke unit and early supported discharge service (ESD) is recommended as an effective
way to improve patient outcome and quality of care following stroke. The ESD service provides
support and rehabilitation for the patients in their own environment and the rehabilitation
is often focused on activities in daily living and mobility.
The objective of this study 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. Furthermore, the study will explore whether
it is feasible and safe for patients with post-stroke fatigue to perform a structured
cardiorespiratory interval training program in their home environment.
Method/design
This is a 1:1 prospective randomized open-label trial (Two-centre study) with blinded
evaluators (PROBE-design) comparing 8 weeks structured cardiorespiratory interval training
program added to standard ESD care compared with standard ESD care alone in 50 patients with
post-stroke fatigue.
Study participants
Consecutive stroke patients who receives stroke unit care followed by ESD-service at Umeå
Stroke Center, University Hospital, Umeå, Sweden and Gävle hospital, Region Gävleborg,
Sweden. A stroke physician will examine the patients 4 (± 1) weeks after discharge from the
stroke unit. The patients fulfilling the eligibility criteria will receive oral and written
information. Thereafter, the potential participants will be given at least 24 hours until
they are asked for written informed consent.
After informed consent, an incremental cardiopulmonary exercise test will be performed on an
ergometer cycle (pre-treatment test). The participants will also estimate post-stroke fatigue
with the Swedish fatigue assessment scale (S-FAS).
Randomization
Participants (N=50) eligible for study participation according to inclusion and exclusion
criteria will be randomly assigned to the intervention group(N=25) or the control
group(N=25). The randomization procedure will be web-based using program Minim. Minimization
will be used to create groups for intervention and control in order to stratify groups and
ensure balance at study entry with respect to significant variables. The participants will be
stratified according to sex, age and stroke severity (Modified Rankin Scale 0-1 vs ≥2).
Treatment
Stroke patients in the control group will receive 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.
The participants in the intervention group will receive structured cardiorespiratory interval
training program on an ergometer cycle. This is in addition to usual ESD care. The training
will be conducted 30-40 minutes, 3 days a week for 8 weeks. Based on the incremental
cardiopulmonary exercise test (pre-treatment test) an individual training heart rate range of
70 to 80% of maximal heart rate (HR peak) will be set. The participants will wear a heart
rate monitor during the training and be instructed to exercise within the heart rate range.
An experienced physiotherapist will be present and guide the training sessions during the
first weeks. When the participants become more familiar with the exercise, the
physiotherapist will monitor the training through phone or telemedicine equipment.
. The training session will start with a 10 minutes warm-up followed by 25 minutes of 4x4
minute interval, at 70 to 80% of peak heart rate, interrupted by 3 minutes active recovery
and 5 minutes cool down. In order to get a estimation of perceived exertion, the participant
will rate on The Borg Rating of Perceived Exertion (RPE) scale every minute during the
4-minute intervals.
Statistical analysis
The sample size was estimated by a power calculation. The power calculation was based on the
level of fatigue assessed with the Swedish Fatigue Assessment scale (primary outcome). The
absolute reliability for the Swedish Fatigue Assessment scale is 9 points, which means that a
9 points change is required to indicate a real change of fatigue level. 21 persons per group
are needed for power of 80 % significance level of 0.05 (2 sided t-test, assuming a standard
deviation of 10). This calculation is based on a t-test assuming a standard deviation of 10
points. A total of 50 participants (25 participants per group) will enter this study. The
analyses of primary and secondary outcome will be on the basis of intension to treat.
Two-sided students t-test or two-sided Wilcoxon signed rank test will be used to compare
groups for the pre-treatment test and post treatment test.