NCT07369453

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Weeks – 75 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Hemiplegia and/or Hemiparesis Following Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-15
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: Turkey (Türkiye)