NCT06633107

Brief Summary

This study aims to explore the effectiveness of cardiac rehabilitation exercise therapy in improving the quality of life of patients with chronic heart failure during hospitalization and after discharge. The specific research content includes screening patients who meet the diagnosis of \"chronic heart failure\" among cardiovascular inpatients from October 2024 to October 2025. Among these patients, those who meet the inclusion criteria and can participate in the study for more than three months are selected. After a detailed explanation, they sign an informed consent form. Finally, eligible patients are included in the study and divided into a control group and an observation group using a random number table method. Various indicators of the enrolled patients are monitored and recorded, including: general information (gender, age, height, weight, BMI, etc.) Educational background, medical history, medication history, laboratory test results, 6-minute walk test results, New York Heart Association (NYHA) cardiac function grading, ultrasound examination results, Minnesota Heart Failure Quality of Life Scale, 1-year mortality assessment for heart failure patients, and prognosis evaluation for chronic heart failure patients. Patients in the control group received routine cardiac rehabilitation guidance; Patients in the observation group receive routine cardiac rehabilitation guidance and develop corresponding rehabilitation exercise therapy prescriptions based on their condition: ① Patients with heart function level I perform slow walking, climbing stairs, and standing aerobic exercises; Grade II patients undergo slow walking and standing aerobic exercises; Grade III patients perform aerobic exercises on bedside seats; Grade IV aerobic exercise on the bed. Guide and supervise two groups of patients to engage in rehabilitation exercises during hospitalization, and record the required indicators during exercise. After discharge, the patient will be followed up for a period of three months. The rehabilitation exercise data will be accurately and completely recorded in the form of a diary by the patient and/or family members, and feedback will be provided weekly, including time, location, exercise time, exercise method, heart rate, and other data. Guidance on home rehabilitation exercise therapy for the observation group: ① Warm up exercise for 5-10 minutes (to awaken the body through warm-up exercise and reduce strains during exercise). Choose the warm-up exercise method according to your own situation, including \"chest expansion exercise, dynamic back extension, standing shoulder activation, foot wrap around the\" 8 \"shape, knee joint warm-up, standing lateral flexion, full body stretching, relaxation jumping, slow jogging in place, and continuous knee strikes\" Aerobic exercise with the help of community sports equipment. The duration gradually increased from 10-20 minutes each time to 30-40 minutes; The intensity gradually increases from 55% maximum heart rate to 60%, not exceeding 85% (maximum heart rate (beats/minute)=220- age (years)); The frequency gradually increased from 3 days/week to 5 days/week; Sports equipment can be selected based on community equipment, such as elliptical machines, Tai Chi massagers, cycling machines, spacewalkers, treadmills, etc Rest (if discomfort occurs during exercise, immediately stop exercising and rest in place). This study used experimental and observational methods to analyze and evaluate various indicator data at admission, discharge, and 3 months of home rehabilitation. Ultimately, it was concluded that cardiac rehabilitation exercise therapy is effective and worthy of promotion in improving the quality of life of patients with chronic heart failure.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Nov 2024Sep 2026

First Submitted

Initial submission to the registry

September 26, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

October 9, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 26, 2024

Last Update Submit

October 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • New York Heart Association (NYHA) Classification of Cardiac Function

    Class I.II. III. IV.

    The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months

Secondary Outcomes (4)

  • NT-proBNP

    The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months

  • 6-minute walking experiment(6MWT)

    The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months

  • Minnesota Heart Failure Quality of Life Scale,MLHFQ

    The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months

  • Ejection fraction

    The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months

Study Arms (2)

experimental group

EXPERIMENTAL

Medically relevant pharmacotherapy combined with rehabilitation exercise therapy. Continued rehabilitation exercise therapy intervention 3 months after discharge.

Behavioral: Cardiac、rehabilitation、exercise

control group

NO INTERVENTION

Only medically relevant medications are given during hospitalization. No rehabilitation exercise therapy intervention for 3 months after discharge.

Interventions

Routine cardiac rehabilitation treatment + corresponding rehabilitation exercise therapy prescription according to the condition: (1) slow walking + stairs climbing + standing aerobic exercise for patients with cardiac function level I; Grade II patients should take slow walking + standing aerobics; Grade III patients undergo bedside chair aerobics; Class IV aerobic exercises on bed. After discharge aerobic exercise with the help of community exercise equipment. The duration is gradually increased from 10-20min to 30-40min each time; Gradually increase the intensity from 55% to 60% of the maximum heart rate and not exceed 85% (maximum heart rate (times / min) = 220 - age (years)); The frequency gradually increased from 3 days/week to 5 days/week

experimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic heart failure
  • NYHA classification of cardiac function of class I. II. III.IV.
  • Must be able to complete the training

You may not qualify if:

  • Cognitive impairment
  • Impairment of physical mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 9, 2024

Study Start

November 30, 2024

Primary Completion

November 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

October 9, 2024

Record last verified: 2024-09