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

Bursa Yuksek Ihtisas Training and Research Hospital

Status: Completed

Conditions: Hemiplegia and/or Hemiparesis Following Stroke

Treatments: Other: Aerobic exercise training using a cycle ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT07369453

2011-KAEK-25 2021/08-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Aerobic Exercise Group

Experimental group

Description:

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.

Treatment:

Other: Aerobic exercise training using a cycle ergometer

Control Group

No Intervention group

Description:

Participants in this group received standard care only, consisting of botulinum toxin type A injections for upper extremity spasticity and conventional rehabilitation.