Actively Recruiting

Phase Not Applicable
Age: 60Years - 75Years
All Genders
ID06588231

Effect of Individualized Exercise Based on CPET on Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-12-31

200

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying elderly patients aged 60 to 75 years who have coronary heart disease confirmed by coronary angiography and stable sinus rhythm. The study evaluates the effects of individualized exercise rehabilitation on cardiovascular risk factors and cardiopulmonary function. Cardiac rehabilitation, recommended by major heart associations, combines drug therapy, exercise, nutrition, psychological and behavioral support, and lifestyle changes to improve symptoms, prognosis, and quality of life in patients with heart disease. The study compares two groups: a control group receiving routine rehabilitation nursing, antiplatelet drugs, lipid-lowering drugs, and dietary guidance, and an exercise group receiving the same medical treatment plus individualized rehabilitation exercise training. The exercise involves medium- to high-intensity interval training three times a week for 16 weeks, with sessions lasting 30 to 40 minutes including warm-up and cool-down periods, tailored to each patient's physical condition. Participants will be monitored for one year, with assessments including gut microbiome analysis, plasma metabolite profiles, walking distance tests (6-minute walk test), LDL cholesterol levels, and peak oxygen uptake (VO2peak). Researchers will track physical, psychological, and social functions, and evaluate how the exercise intervention influences cardiovascular risk and heart and lung function. This comprehensive follow-up aims to understand long-term benefits and safety of the rehabilitation program.

CONDITIONS

Brief Title

Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease

Who Can Participate

Age: 60Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Coronary heart disease confirmed by coronary angiography
  • Age between 60 and 75 years old with stable clinical sinus rhythm
  • Left ventricular ejection fraction greater than 40%
  • Informed consent and voluntary participation
Not Eligible

You will not qualify if you...

  • Severe organic heart and lung diseases
  • Hemiplegia or other physical movement disorders
  • History of mental illness
  • Uncontrolled hypertension or hemodynamic instability
  • Severe kidney disease or severe peripheral artery disease
  • Bone and joint diseases not suitable for exercise
  • Uncontrolled endocrine or other systemic diseases
  • Use of antibiotics or anti-diarrheal medications within the past 3 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 2 weeks

Participants undergo 2 weeks of adaptive exercise training to ensure safety and suitability for the study.

Sessions 3 times a week

Treatment

Duration - 16 weeks

Participants in the exercise group perform individualized moderate to high intensity interval training 3 times a week for 16 weeks under specialist guidance. The control group receives routine antiplatelet drugs and lipid-lowering drugs after operation along with dietary and lifestyle advice.

Exercise sessions 3 times a week lasting 30-40 minutes each

Follow-up

Duration - Up to 1 year

Participants are monitored for cardiovascular risk factors and cardiopulmonary function outcomes up to one year after treatment.

Periodic visits over one year for assessment

Trial Site Locations

Total: 1 location

1

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

L

Leilei Chen

M

Mei Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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