Does Cardiorespiratory Interval Training Improve Post-stroke Fatigue

May 10, 2024 updated by: Anna Brandal, Umeå University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Umeå, Sweden, s-90185
        • Recruiting
        • Anna Bråndal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiorespiratory interval training
Cardiorespiratory interval training program on ergometer cycle, 30-40 minutes, 3 days a week for 8 weeks.
Other: Cardiorespiratory interval training
A structured cardiorespiratory interval training program on an ergometer cycle 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-stroke fatigue
Time Frame: The S-FAS will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness (Peak oxygen consumption, VO2peak)
Time Frame: Cardiorespiratory fitness (peak oxygen consumption) will be measured before intervention (pre-treatment test) and immediately after end of 8 week intervention (post-treatment test)
Cardiorespiratory fitness will be determined by measuring peak oxygen consumption (VO2peak) in an incremental cardiopulmonary exercise test on a ergometer cycle
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)
Time Frame: Fidelity will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Fidelity will be measured by recording the number of sessions completed.
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)
Time Frame: Adherence will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Adherence will be measured by monitoring heart rate (HR) during the exercise
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)
Time Frame: Adverse events will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks
Adverse events will be recorded by asking the participants to fill in a home-exercise logbook at each training session and reviewing hospital record.
Adverse events will be measured throughout the intervention and will be monitored at each individual training session, 3 days a week for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umeå University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Västerbotten

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Bråndal, PhD, Department of Community Medicine and Rehabilitation, Physotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-420-31M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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