Exercise to Improve Sleep and Quality of Life in Stroke Patients Receiving Botulinum Toxin Treatment

January 18, 2026 updated by: Merve Yeni, Bursa Yuksek Ihtisas Training and Research Hospital

The Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated With Botulinum Toxin for Upper Extremity Spasticity

This study aimed to investigate the contribution of aerobic exercise programmes to improving sleep quality, quality of life, and functional status, alongside conventional rehabilitation, in stroke patients who had received botulinum toxin treatment for upper extremity spasticity.

Study Overview

Status

Status

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

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

This randomized controlled trial included 62 chronic stroke patients receiving BTX-A injections for upper extremity spasticity. Participants were randomized into two groups: one that participated in a 4-week aerobic exercise program and a control group that received conventional rehabilitation without aerobic exercise. The primary outcomes were functional independence, upper extremity motor development, walking speed, sleep quality and quality of life.

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 (Actual)

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.
56

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 Locations

  • Turkey (Türkiye)
    • Turkey
      • Bursa, Turkey, Turkey (Türkiye), 16130
        • Bursa Yuksek Ihtisas Training and Research Hospital

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 62 patients aged 18-75 years who were planned for botulinum toxin treatment due to upper extremity spasticity following a stroke

Exclusion Criteria:

  • Stroke patients who had BTX-A injections for lower extremity spasticity or had a Modified Ashworth Scale (MASH) score ≥ 2 for lower extremity spasticity,
  • Uncontrolled diabetes, hypertension, cardiovascular diseases,
  • Cognitive dysfunction,
  • Flaccid stroke,
  • Upper extremity disorders (fractures, frozen shoulder, arthritis, surgery),
  • Pre-existing sleep disorders (obstructive sleep apnea, insomnia, parasomnia, narcolepsy, restless leg syndrome, or psychiatric disorders),
  • Cancer diagnosis,
  • Those who had received antispastic or antiepileptic treatment with dose changes in the last month

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: Aerobic Exercise Group
Participants in this group received a supervised low- to moderate-intensity aerobic exercise program in addition to standard care. The aerobic exercise program was performed three times per week for four weeks, with 30-minute sessions consisting of warm-up, exercise, and cool-down periods. All participants also received botulinum toxin type A injections and conventional rehabilitation as part of routine clinical care.
Other: Aerobic exercise training using a cycle ergometer
A stationary cycling ergometer was used to deliver the supervised aerobic exercise intervention. The device was used for low- to moderate-intensity aerobic training at 40-60% of maximum heart rate, three sessions per week for four weeks, under medical supervision. The cycle ergometer is used solely as an exercise modality and is not the investigational product of the study.
No Intervention: Control Group
Participants in this group received standard care only, consisting of botulinum toxin type A injections for upper extremity spasticity and conventional rehabilitation.

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
Functional Recovery, Sleep, and Quality of Life Outcomes
Time Frame: From baseline to 12 weeks after starting the exercise program
Health-related quality of life will be assessed using the Euroqol Quality of Life Scale, which evaluates mobility, selfcare, usual activities, pain and depression, with higher index values indicating better quality of life. Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (0-24), where higher scores indicate greater sleepiness. Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (0-21), with higher scores indicating poorer sleep quality. Activities of daily living will be assessed using the Barthel Index (0-20). Functional independence will be evaluated using the Functional Independence Measure (18-126), with higher scores indicating greater independence. Neurological and motor recovery will be assessed using Brunnstrom stages, upper extremity motor function using the Fugl-Meyer Assessment of the Upper Extremity (0-66) and spasticity using the Modified Ashworth Scale. Functional exercise capacity will be assessed using the 6-Minute Walk Test.
From baseline to 12 weeks after starting the exercise program
Effects of Aerobic Exercise on Sleep Quality, Quality of Life, and Functional Status in Stroke Patients Treated with BTX-A for Upper Extremity Spasticity
Time Frame: From baseline to 12 weeks after starting the exercise program
From baseline to 12 weeks after starting the exercise program

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.
Bursa Yuksek Ihtisas Training and Research Hospital

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.
September 15, 2021

Primary Completion (Actual)

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.
January 15, 2024

Study Completion (Actual)

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.
January 15, 2024

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).
December 23, 2025

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.
January 18, 2026

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.
January 27, 2026

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.
January 27, 2026

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.
January 18, 2026

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.
January 1, 2026

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.
  • 2011-KAEK-25 2021/08-12

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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