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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subacute Stroke
• Intervention / Treatment: Behavioral: Standard Physical Therapy; Behavioral: Aerobic Exercise With Music

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minh Tu Trinh, MD; Phone Number: +84947969399; Email: tmtu.ncs25@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh
    • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700157
      • Recruiting
      • Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A)
      • Contact: Minh Tu Trinh, MD; Phone Number: +84947969399; Email: tmtu.ncs25@ump.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group: Standard Physical Therapy; Participants in the control arm will receive the standard inpatient physical therapy program routinely applied at the hospital. The standard physical therapy includes assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes per session), and occupational therapy exercises for activities of daily living (30 minutes per session). Training is conducted by certified physiotherapists, 1 session/day, 5 days/week, for 6 consecutive weeks during hospitalization. No aerobic exercise with music is provided in this arm.	Behavioral: 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.
Experimental: Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy; Participants receive the standard inpatient physical therapy program, including assisted range-of-motion exercises for upper and lower limbs and trunk, balance training, coordination exercises (30 minutes/session), and occupational therapy for activities of daily living (30 minutes/session). In addition, they complete a 30-minute supervised aerobic exercise program with music, 1 session/day, 5 days/week for 6 weeks. Exercises include breathing control, neck mobility, shoulder elevation, cross-body arm reaches, elbow, wrist and hand movements, trunk rotation, forward flexion, seated marching, and supported standing arm lifts, trunk rotation, high-knee marching, and step-forward/back drills. Music tempo is phase-specific: warm-up 60-70 bpm, main session 80-110 bpm, cool-down 50-60 bpm. Heart rate is monitored with a smart wristband, with intensity limited to 60% of the individual target heart rate calculated using the Karvonen formula.	Behavioral: 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.; Behavioral: 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. Music tempo is phase-specific: warm-up 60-70 bpm, main session 80-110 bpm, cool-down 50-60 bpm. Heart rate is monitored with a smart wristband and limited to 60% of the individual target heart rate, calculated using the Karvonen formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Upper Extremity (FMA-UE) Score	The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluates motor function, coordination, reflexes, sensation, joint pain, and passive joint motion. Scores range from 0 to 126, with higher scores reflecting better motor recovery. This primary outcome measures the change in total FMA-UE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).	6 weeks after intervention
Change in Fugl-Meyer Lower Extremity (FMA-LE) Score	The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) evaluates reflexes, motor control of the hip, knee, and ankle, coordination, sensation, joint pain, and passive joint motion. Scores range from 0 to 86, with higher scores indicating better lower-limb motor recovery. This primary outcome measures the change in total FMA-LE score from baseline (T0) to 6 weeks (T1) between the intervention group (aerobic exercise with individualized music) and the control group (standard rehabilitation only).	6 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Barthel Index Score	The Barthel Index evaluates independence in activities of daily living including feeding, bathing, dressing, toileting, continence, transfers, mobility, and stair climbing. Scores range from 0 to 100, with higher scores representing greater independence. This secondary outcome measures the change in Barthel Index from baseline (T0) to 6 weeks (T1).	6 weeks after intervention
Change in PHQ-9 Depression Score	The PHQ-9 assesses depressive symptoms across 9 items scored 0-3. Total scores range from 0 to 27. Higher scores reflect more severe depression. This outcome measures the change in PHQ-9 score from baseline to 6 weeks.	6 weeks after intervention
Change in Berg Balance Scale (BBS) Score	The Berg Balance Scale includes 14 balance tasks, each scored 0-4. Total scores range from 0 to 56, with higher scores indicating better balance. This outcome evaluates change in BBS score from baseline to 6 weeks.	6 weeks after intervention
Change in NIH Stroke Scale (NIHSS) Score	The NIHSS measures stroke severity including consciousness, gaze, motor strength, sensation, language, and neglect. Scores range from 0 (normal) to 42 (severe stroke). This outcome assesses the change in NIHSS score from baseline to week 6.	6 weeks after intervention
Change in Mini-Mental State Examination (MMSE) Score	The MMSE evaluates global cognition including orientation, attention, memory, language, and visuospatial skills. Scores range from 0 to 30. This outcome assesses change in MMSE score from baseline to 6 weeks.	6 weeks after intervention
Exercise-Related Adverse Events	Adverse events include dizziness, falls, hypoglycemia, muscle pain, or other symptoms that prevent continuation of aerobic exercise. All events will be recorded throughout the 6-week intervention period.	During the 6-week intervention

Collaborators and Investigators

• Sponsor: Trịnh Minh Tú
• Investigators: Principal Investigator: Minh Tu Trinh, MD, Ho Chi Minh City Orthopedics and Rehabilitation Hospital (Hospital 1A)

Publications and helpful links

General Publications

• Dimitriadis T, Mudarris MA, et al. Music therapy with adults in the subacute phase after stroke: study protocol. Front Neurol. 2024;15:123456.
• Moncion K, Rodrigues L, et al. Aerobic exercise interventions for promoting cardiovascular health and mobility after stroke: a systematic review with Bayesian network meta-analysis. J Stroke Cerebrovasc Dis. 2023;32(8):106-115.
• 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, et al. Aerobic exercise recommendations to optimize best practices in care after stroke: AEROBICS 2019. Physical Therapy. 2020;100(4):000-000.
• Mang CS, Campbell KL, Ross CJ, Boyd LA. Promoting neuroplasticity for motor rehabilitation after stroke: considering the effects of aerobic exercise and genetic variation. Neuroscientist. 2013;19(3):313-331.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: AERO-MUSIC-STROKE-HCMC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the dataset contains personal health information of patients and cannot be shared publicly under institutional and national privacy regulations. Only aggregated, de-identified results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No