Hemiplegia and/or Hemiparesis Following Stroke
Conditions
Keywords
Botox, Aerobic Exercise, Spasticity, Sleep
Brief 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.
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.
Interventions
OTHERAerobic 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.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Weeks to 75 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Recovery, Sleep, and Quality of Life Outcomes | 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 | From baseline to 12 weeks after starting the exercise program | — |
Countries
Turkey (Türkiye)
Outcome results
None listed