Hemiplegia and/or Hemiparesis Following StrokeNCT07369453
Exercise to Improve Sleep and Quality of Life in Stroke Patients Receiving Botulinum Toxin Treatment
A study testing Aerobic exercise training using a cycle ergometer in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 weeks
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- Aerobic exercise training using a cycle ergometer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 62 patients aged 18-75 years who were planned for botulinum toxin treatment due to upper extremity spasticity following a stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey, 16130
About this study
Official title: 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.
Read the 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.
- Being tested
- Aerobic exercise training using a cycle ergometer
- Keywords
- Botox, Aerobic Exercise, Spasticity, Sleep
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise training using a cycle ergometerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | 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. Receives: Other: Aerobic exercise training using a cycle ergometer |
| Control Group | No intervention | Participants in this group received standard care only, consisting of botulinum toxin type A injections for upper extremity spasticity and conventional rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Recovery, Sleep, and Quality of Life Outcomes
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.
Measured: 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
Measured: From baseline to 12 weeks after starting the exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Sep 2021
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Yeni, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369453
- Sponsor's protocol ID
- 2011-KAEK-25 2021/08-12
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07369453
- Acronym / sponsor ID
- 2011-KAEK-25 2021/08-12
- Keywords
- Botox, Aerobic Exercise, Spasticity, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Other: Aerobic exercise training using a cycle ergometerParticipants 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. |
| Control Group | No intervention | –Participants in this group received standard care only, consisting of botulinum toxin type A injections for upper extremity spasticity and conventional rehabilitation. |
Who may qualify
- Ages
- 18 to 75 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 62 patients aged 18-75 years who were planned for botulinum toxin treatment due to upper extremity spasticity following a stroke
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise training using a cycle ergometerA 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. | Other | Aerobic Exercise Group |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training using a cycle ergometer in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery, Sleep, and Quality of Life Outcomes (time frame: From baseline to 12 weeks after starting the exercise program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.