The effect of early rehabilitation nursing
| ISRCTN | ISRCTN18094960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18094960 |
| Construction and Empirical Study of Pre hospital Emergency Training Program for Family Members of High Risk Sudden Cardiac Death Patients Based on Action Promotion Theory grant number | HNSYHLKT202209 |
| Research on Multidisciplinary Digital Health Management Model for Post PCI Patients in the Metaverse Perspective grant number | LHGJ20230059 |
| Sponsor | Henan Provincial People's Hospital |
| Funder | Henan Provincial People's Hospital |
- Submission date
- 24/12/2025
- Registration date
- 30/12/2025
- Last edited
- 29/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Acute myocardial infarction (AMI) is a common life-threatening cardiovascular disease characterised by rapid onset, severe clinical manifestations and poor prognosis.Percutaneous coronary intervention (PCI)is currently a key treatment for AMI, as it can rapidly restore myocardial blood supply, reduce myocardial damage and improve survival rates. Early rehabilitation nursing is an evidence-based approach that promotes rapid recovery and improves long-term prognosis.This study aimed to investigate the effect of implementing early rehabilitation nursing on the recovery of cardiac function indices and prognosis after PCI treatment in patients with AMI.
Who can participate?
Patients diagnosed with AMI and treated with PCI.
What does the study involve?
The control group received routine nursing after surgery, whereas the observation group received structured early rehabilitation nursing.
What are the possible benefits and risks of participating?
Early rehabilitation nursing for patients with AMI can effectively improve patients' cardiac function indices and reduce the risk of MACE, thereby improving their quality of life.
The main risks are the occurrence of major adverse cardiovascular events and their impact on quality of life.
Where is the study run from?
Henan Provincial People's Hospital, China.
When is the study starting and how long is it expected to run for?
February 2020 to June 2025.
Who is funding the study?
Henan Provincial People's Hospital, China.
Who is the main contact?
Qingzhu Qin, QZW_wwqin2526@163.com
Contact information
Principal investigator, Scientific, Public
No. 7 Weiwu Road, Jinshui District
Zhengzhou City
450000
China
| Phone | +86-18790658671 |
|---|---|
| QZW_wwqin2526@163.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Supportive care | |
| Scientific title | The effect of early rehabilitation nursing on the recovery of cardiac function in patients with acute myocardial infarction | |
| Study objectives | ||
| Ethics approval(s) |
Approved 01/04/2024, Medical Ethics Committee of Henan Provincial People's Hospital (No. 7 Weiwu Road, Jinshui District, , Henan Province,China, Zhengzhou City, 450000, China; +86-037165580014; fengzwmmnn9@21cn.com), ref: (2024) Ethical Approval No. (59) | |
| Health condition(s) or problem(s) studied | Patients diagnosed with acute myocardial infarction and treated with percutaneous coronary intervention | |
| Intervention | A structured, phase-specific protocol was implemented by trained cardiac nurses, starting within 24 hours after PCI (initiation criteria: stable vital signs, no active bleeding at the puncture site and absence of severe chest pain/dyspnoea). The protocol was divided into three phases, as described below： Phase 1 Postoperative day 1 - Bedside care: assist with bed rest, urination/defecation; turn every 2 hours to prevent pressure ulcers. - Passive exercises: range-of-motion (ROM) training for non-operative limbs. - Breathing exercises: deep breathing and coughing exercises. - Psychological support: explain the rehabilitation plan and address concerns. - Turning: every 2 hours - Breathing exercises: 2 times/d, 10–15 min/time - ROM training: 1 time/d, 5–10 min/time Cardiac nurses Phase 2 Postoperative days 2–3 - Active exercises: active ROM training for all limbs; semi-recumbent/sitting position exercises (12 hours after puncture site haemostasis). - Bedside standing: 5–10 min/ session. - Daily living training: brushing teeth, washing face (assisted). - Health education: emphasise adherence to rehabilitation. - Active exercises: 2 times/d, 10–15 min/time - Standing: 2 times/d Cardiac nurses + family caregivers (trained by nurses) Phase 3 Postoperative days 4–7 - Ambulation: ward/hallway walking (tolerated by patients: 75–100 m on day 4; 200–350 m on day 5; progressive increase on days 6–7). - Strength training: supine leg extension, arm raising and squatting (avoiding Valsalva manoeuvre). - Diet guidance: low-salt, low-fat, high-fibre diet. - Walking: 1–2 times/d, duration based on tolerance - Strength training: 1 time/d, 10–15 min/time Cardiac nurses Discharge and post-discharge Postoperative day 7 to 6 months - Discharge planning: individualised home exercise programme (10–15 min/d walking, target heart rate 85–90 beats/min). - Follow-up: monthly telephone calls + 3-month outpatient visits to monitor compliance and adjust the plan. - Emergency guidance: advise reducing/stopping exercise if chest tightness/sweating occurs. - Home exercise: daily - Follow-up: monthly (telephone) + 3-month (outpatient) Cardiac nurses Randomisation was performed by an independent statistician, and group allocation was concealed using sequentially numbered, opaque envelopes. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 35 Years |
| Upper age limit | 72 Years |
| Sex | All |
| Target sample size at registration | 314 |
| Total final enrolment | 314 |
| Key inclusion criteria | 1. Meeting the diagnostic criteria in the Diagnostic and Therapeutic Guidelines for Acute Myocardial Infarction 2. Complete clinical data 3. New York Heart Association (NYHA) classification II–IV 4. No serious complications (e.g. severe infection, organ failure) or contraindications to rehabilitation 5. Patients and their families provided informed consent |
| Key exclusion criteria | 1. Comorbidity with other major diseases (e.g. malignant tumours, end-stage renal disease) 2. Contraindications to PCI or rehabilitation (e.g. severe arrhythmia, haemodynamic instability) 3. Poor compliance (refusal to participate in rehabilitation or follow-up) 4. Comorbid psychiatric disorders, audio-visual impairment or speech disorders |
| Date of first enrolment | 20/02/2020 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
24/12/2025: Study’s existence confirmed by the Medical Ethics Committee of Henan Provincial People's Hospital, China.
