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

Bursa Yuksek Ihtisas Training and Research Hospital56 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Interventions

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.

Eligibility

Sex: ALLMin age: 18 WeeksMax age: 75 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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

Data from ClinicalTrials.gov

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