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

NCT07369453 | Completed DMC

• 1 other identifier: 2011-KAEK-25 2021/08-12
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Keywords

Botox; Aerobic Exercise; Spasticity; Sleep

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  From baseline to 12 weeks after starting the exercise program

Study Arms (2)

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.

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.

Interventions

Aerobic exercise training using a cycle ergometer OTHER

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.

Aerobic Exercise Group

Eligibility Criteria

• Age: 18 Weeks - 75 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey, 16130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 27, 2026
• Study Start: September 15, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (1)