NCT07503522

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026May 2028

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 25, 2026

Last Update Submit

April 8, 2026

Conditions

Subacute Stroke

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Change in Barthel Index Score

    6 weeks after intervention

  • Change in PHQ-9 Depression Score

    6 weeks after intervention

  • Change in Berg Balance Scale (BBS) Score

    6 weeks after intervention

  • Change in NIH Stroke Scale (NIHSS) Score

    6 weeks after intervention

  • Change in Mini-Mental State Examination (MMSE) Score

    6 weeks after intervention

  • +1 more secondary outcomes

Study Arms (2)

Control Group: Standard Physical Therapy

ACTIVE COMPARATOR

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

Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy

EXPERIMENTAL

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 TherapyBehavioral: Aerobic Exercise With Music

Interventions

Standard Physical TherapyBEHAVIORAL

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.

Control Group: Standard Physical TherapyIntervention Group: Aerobic Exercise With Music + Standard Physical Therapy
Aerobic Exercise With MusicBEHAVIORAL

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.

Intervention Group: Aerobic Exercise With Music + Standard Physical Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ho Chi Minh City, Ho Chi Minh, 700157, Vietnam

RECRUITING

Related Publications (5)

  • Dimitriadis T, Mudarris MA, et al. Music therapy with adults in the subacute phase after stroke: study protocol. Front Neurol. 2024;15:123456.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Minh Tu Trinh, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh Tu Trinh, MD

CONTACT

+84947969399tmtu.ncs25@ump.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention group or the control group in a parallel design. The control group will receive standard physical therapy, while the intervention group will receive standard therapy plus a music-based aerobic exercise program. Randomization is conducted through block randomization with permuted block size. Both groups will be followed concurrently for 6 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Level II Physician, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

VN(1)