EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangdong Provincial People's Hospital

About this trial

EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18-80

Able to independently perform basic activities of daily living before admission.

Able to complete the baseline assessment and initiate the specified treatment.

Able to walk 4 meters at the time of enrollment (assistive devices may be used).

Disqualifiers

Acute heart failure caused by acute myocardial infarction.

Severe aortic valve stenosis.

Hemodynamic instability caused by poorly controlled arrhythmias.

Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early comprehensive rehabilitation

    Behavioral

    Patients randomized to the rehabilitation intervention group will be offered comprehensive rehabilitation plan containing 18 sessions of a structured outpatient-based exercise program over 6 weeks (3 times per week).

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Rehabilitation Intervention GroupActive comparator 1 intervention
Group B: Attention ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

Time frame
Baseline and Week 6
2

Maximal Inspiratory Pressure as a Percentage of Predicted Value (PImax%pred)

Participants will tries their best to exhale to the residual position, and then inhale as much as possible for 2\~3 seconds to measure PImax and the percentage of PImax%pred

Time frame
Baseline and Week 6

Secondary outcomes

1

Score of Short Physical Performance Battery (SPPB)

The SPPB measures physical function using 3 components: standing balance with progressively narrow base of support, usual gait speed over 4 meters, and time to complete 5 chair rises. The total score ranges from 0 to 12, with higher scores indicating better physical function.

Time frame
Baseline and Week 6
2

Score of Frailty

Patients were classified as frail if they met three or more of the following criteria: weak grip strength, physical exhaustion, slowness, low physical activity and unintentional weight loss.

Time frame
Baseline and Week 6
3

Pulmonary Function

Measurements of forced vital capacity and forced expiratory volume in 1 s were obtained with a computerized spirometer.

Time frame
Baseline and Week 6
4

Rate of All-Cause Rehospitalization

Number of all-cause rehospitalizations 6 months from hospital discharge.

Time frame
Month 6

Other outcomes

1

Score of Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)

The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.

Time frame
Baseline and Week 6
2

Score of Anxiety

Anxiety is assessed by General Anxiety Disorder-7. Score ranges from 0 to 21 points, with higher scores indicating more severe anxiety.

Time frame
Baseline and Week 6
3

Score of Depression

Depression is assessed by Patient Health Questionnaire-9. Score of Patient Health Questionnaire-9 ranges from 0 to 27 points, with higher scores indicating more severe mood depression.

Time frame
Baseline and Week 6
4

Left ventricular ejection fraction (LVEF)

Using Echocardiography to assess the left ventricular ejection fraction (LVEF)

Time frame
Baseline and Week 6

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