Personalized Music-Enhanced Aerobic Training for Patients in Subacute Stroke Recovery

Официальное название

Evaluation of the Effectiveness of a Personalized Music-Based Aerobic Exercise Rehabilitation Program for Patients With Subacute Stroke

Обзор

This study aims to evaluate the effectiveness of a personalized music-based aerobic exercise program designed specifically for inpatients in the subacute phase of stroke. All participants will receive the hospital's standard physical therapy program. In addition, the intervention group will participate in 30-minute music-based aerobic exercise sessions, 5 days per week, for a total of 6 weeks. The aerobic exercises are gentle and adapted to the functional abilities of individuals with subacute stroke. The exercises incorporate rhythmic music to guide movements of the arms, legs, and trunk, with the goal of improving mobility, balance, and mood. Participants will have their heart rate monitored and will be supervised directly by rehabilitation therapists throughout all sessions to ensure safety. Outcomes will be assessed before and after the 6-week intervention using standardized measures of motor function, balance, depressive symptoms, and independence in daily activities. The study does not interfere with participants' routine medical treatment and does not require discontinuation of any ongoing therapies. Risks associated with participation are generally mild and similar to those of routine therapeutic exercise, such as muscle soreness, dizziness, or risk of falls. All potential risks will be minimized through continuous supervision by trained healthcare staff. Participants may withdraw from the study at any time. Potential benefits for participants include improved mobility, better balance, reduced depressive symptoms, increased independence in daily living, and enhanced motivation during rehabilitation through the use of music. The study also aims to provide scientific evidence for the effectiveness of music-based aerobic exercise in stroke rehabilitation in Vietnam.

Подробное описание

Subacute stroke represents a critical window for neurological recovery, during which neuroplasticity is heightened and rehabilitation interventions may have a stronger impact on long-term functional outcomes. Despite receiving standard inpatient rehabilitation, many patients continue to experience persistent limitations in mobility, balance, and emotional well-being. There is growing evidence that aerobic exercise can enhance neuroplasticity, improve cardiovascular fitness, and support motor relearning during stroke recovery. Music-based rehabilitation approaches, including rhythmic auditory stimulation, have also been shown to facilitate coordinated movement, increase engagement, and positively influence mood.

However, most aerobic exercise protocols studied internationally-such as treadmill walking, stationary cycling, or moderate-to-high intensity regimens-are not feasible for many patients in the subacute phase because of weakness, impaired balance, or restricted mobility. There is a need for accessible, adaptable, and lower-intensity aerobic interventions that can be delivered safely during inpatient rehabilitation without requiring specialized equipment.

This study was designed to address this gap by developing a structured music-based aerobic exercise program tailored to the physical capacity of individuals with subacute stroke. The intervention incorporates rhythmic music with clear tempo cues to support timing, pacing, and coordination of limb and trunk movements. The exercise sequence includes warm-up, rhythmic aerobic movements, and cool-down, and may be performed in either a seated or supported standing position depending on each participant's functional ability. Music selections are chosen to provide stable rhythm, moderate tempo, and a motivating emotional tone, which may enhance participation and therapeutic engagement.

The trial uses a randomized controlled design to investigate whether adding this structured music-based aerobic program to standard inpatient rehabilitation produces additional improvements over a 6-week period. The conceptual foundation for this intervention draws from principles of neurologic music therapy, aerobic conditioning guidelines for individuals post-stroke, and emerging evidence that music can improve movement synchronization, attentional focus, and emotional regulation.

Safety is an integral component of the study design. The intervention was created specifically to avoid complex or destabilizing movements and to remain within a mild-to-moderate intensity range appropriate for subacute stroke patients. Continuous supervision by rehabilitation therapists and monitoring of vital signs aim to ensure that the program remains safe and well tolerated. The study also includes procedures for identifying, documenting, and managing adverse events and for adjusting the protocol as necessary to maintain participant safety.

By evaluating this structured, culturally adapted music-based aerobic program within an inpatient setting, the study aims to generate practical evidence on its feasibility, safety, and potential therapeutic value. The findings may help guide future recommendations for incorporating rhythmic and music-based interventions into early stroke rehabilitation and may contribute to the development of rehabilitation protocols that are more engaging, motivating, and tailored to patient needs within the Vietnamese healthcare context.

Вмешательства

• Поведенческое Standard Physical Therapy
  Standard inpatient physical therapy including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy for activities of daily living (30 minutes per session). Training is delivered once per day, 5 days per week, for 6 weeks during hospitalization.
• Поведенческое Aerobic Exercise With Music
  A supervised 30-minute aerobic exercise program with music, delivered 1 session per day, 5 days per week for 6 weeks, in addition to standard physical therapy. Exercises are adapted for seated or supported standing stroke patients and include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, supported standing arm lifts, trunk rotation, high-knee marching, and step-forward/back drills.

Первичные конечные точки

• Change in Fugl-Meyer Upper Extremity (FMA-UE) Score [Срок оценки: 6 weeks after intervention]
• Change in Fugl-Meyer Lower Extremity (FMA-LE) Score [Срок оценки: 6 weeks after intervention]

Вторичные конечные точки (6)

• Change in Barthel Index Score [Срок оценки: 6 weeks after intervention]
• Change in PHQ-9 Depression Score [Срок оценки: 6 weeks after intervention]
• Change in Berg Balance Scale (BBS) Score [Срок оценки: 6 weeks after intervention]
• Change in NIH Stroke Scale (NIHSS) Score [Срок оценки: 6 weeks after intervention]
• Change in Mini-Mental State Examination (MMSE) Score [Срок оценки: 6 weeks after intervention]
• Exercise-Related Adverse Events [Срок оценки: During the 6-week intervention]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Clinically and radiologically confirmed diagnosis of subacute stroke.
• Able to understand and respond to assessment questions.
• No significant visual or hearing impairment.
• Mini-Mental State Examination (MMSE) ≥ 10.
• Able to sit unsupported.
• Provided informed consent (patient or legal representative).

Критерии исключения

• Recent myocardial infarction or congestive heart failure.
• Severe cardiac arrhythmia or resting systolic blood pressure > 200 mmHg.
• Hypertrophic cardiomyopathy or severe aortic stenosis.
• Musculoskeletal disorders contraindicating exercise.
• Psychiatric disorders interfering with participation.
• Severe aphasia preventing assessment.
• Moderate-to-severe dementia (MMSE ≤ 9).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A) — Ho Chi Minh City

Публикации

• Dimitriadis T, Mudarris MA, Veldhuijzen DS, Evers AWM, Magee WL, Schaefer RS. Music therapy with adults in the subacute phase after stroke: A study protocol. Contemp Clin Trials Commun. 2024 Jul 25;41:101340. doi: 10.1016/j.conctc.2024.101340. eCollection 2024 Oct. PMID 39188414
• Moncion K, Rodrigues L, Wiley E, Noguchi KS, Negm A, Richardson J, MacDonald MJ, Roig M, Tang A. Aerobic exercise interventions for promoting cardiovascular health and mobility after stroke: a systematic review with Bayesian network meta-analysis. Br J Sports Med. 2024 Mar 21;58(7):392-400. doi: 10.1136/bjsports-2023-107956. PMID 38413134
• Gonzalez-Hoelling S, et al. Effects of rhythmic auditory stimulation on gait and balance in subacute stroke: A randomized controlled trial. NeuroRehabilitation. 2021;48(1):45-57.
• MacKay-Lyons M, Billinger SA, Eng JJ, Dromerick A, Giacomantonio N, Hafer-Macko C, Macko R, Nguyen E, Prior P, Suskin N, Tang A, Thornton M, Unsworth K. Aerobic Exercise Recommendations to Optimize Best Practices in Care After Stroke: AEROBICS 2019 Update. Phys Ther. 2020 Jan 23;100(1):149-156. doi: 10.1093/ptj/pzz153. PMID 31596465
• Mang CS, Campbell KL, Ross CJ, Boyd LA. Promoting neuroplasticity for motor rehabilitation after stroke: considering the effects of aerobic exercise and genetic variation on brain-derived neurotrophic factor. Phys Ther. 2013 Dec;93(12):1707-16. doi: 10.2522/ptj.20130053. Epub 2013 Aug 1. PMID 23907078

Идентификаторы

NCT: NCT07503522 · AERO-MUSIC-STROKE-HCMC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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