- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06633107
The Impact of Cardiac Rehabilitation Exercise Therapy on the Quality of Life of Patients With Chronic Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: He
- Phone Number: +86 13883745781
- Email: 395336869@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of chronic heart failure
- NYHA classification of cardiac function of class I. II. III.IV.
- Must be able to complete the training
Exclusion Criteria:
- Cognitive impairment
- Impairment of physical mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
Medically relevant pharmacotherapy combined with rehabilitation exercise therapy.
Continued rehabilitation exercise therapy intervention 3 months after discharge.
|
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 |
|
No Intervention: control group
Only medically relevant medications are given during hospitalization.
No rehabilitation exercise therapy intervention for 3 months after discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
New York Heart Association (NYHA) Classification of Cardiac Function
Time Frame: The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Class I.II. III. IV.
|
The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NT-proBNP
Time Frame: The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Overall standard: The normal value is less than 300 ng / L. Age stratification: < 50 years: NT-probnp levels greater than 450 ng / L may indicate acute heart failure.
50-75 years: NT-probnp levels greater than 900 ng / L may indicate acute heart failure.
Age 75 and older: NT-probnp levels greater than 1800 ng/ L may indicate acute heart failure.
NT-probnp > 1200 ng / L may indicate acute heart failure if the patient has renal insufficiency (eg, GFR < 60 ml/ min).
|
The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
|
6-minute walking experiment(6MWT)
Time Frame: The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Severe heart failure:6MWD is less than 150meters Moderate heart failure:6MWD is 150 to 450meters Mild heart failure:6MWD is more than 450meters
|
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
Time Frame: The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
The MLHFQ has 21 entries measuring the quality of life from three domains: the physical domain (entries 2, 3, 4, 5, 6, 7, 12, 13), the emotional domain (entries 17, 18, 19, 20, 21) and the other domains (entries 1, 8, 9, 10, 11, 14, 15, 16).
Each MLHFQ entry is a 6-paragraph scoring method with 0-5 points.
The original minimum score for each entry is 0 (best), the highest score is 5 (worst), and the total score for each entry is added up.
As a result, the original combined score of 21 entries was 0 (best) to 105 (worst); The physical area scores are 0 (best) to 40 (worst), the emotional area scores is 0 (best), 25 (worst) and the other areas scores are zero (best) and 40 (worse).
Higher scores indicate poorer quality of life, and lower scores mean better quality of life.
|
The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
|
Ejection fraction
Time Frame: The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Ejection fraction (EF) is the percentage of stroke output as a percentage of the ventricular end-diastolic volume.
The normal value is 50-70%.
Left ventricle ejection fraction (LVEF): Normal range: 55% -65%.
Right ventricle ejection fraction: normal range: ≥ 40%.
|
The first day of hospitalized;The last day of hospitalized;Through study completion, an average of 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMCIIT240908
- B202437 (Other Grant/Funding Number: Chongqing Administration of Sport)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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