Effect of evidence-driven computerised rule-guided exercise prescription combined with closed-loop remote supervision

Effect of evidence-driven computerised rule-guided exercise prescription combined with closed-loop remote supervision on vascular patency and exercise compliance after lower extremity arteriosclerosis obliterans surgery

Registry ID
ISRCTN25686858
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Shanxi Academy of Medical Sciences
Enrollment
88
Start date
2026-03-18
Completion date
2027-02-28
Last update
2026-08-17

Conditions

Summary

Postoperative exercise rehabilitation intervention for postoperative patients with lower extremity arteriosclerosis obliterans and Fontaine ischemia grade II

Detailed description

This is a prospective, single-centre, parallel-group randomized controlled trial. A random sequence was generated using SPSS version 26.0. The allocation results of the groups were concealed using sealed opaque envelopes. 88 patients were randomly divided into the study group and the control group at a 1:1 ratio according to the random number table, with 44 patients in each group. The control group receives routine exercise guidance covering the preoperative, in-hospital, discharge and post-discharge stages: preoperatively, the responsible nurse provides oral health education and distributes a paper-based general exercise manual; during postoperative hospitalisation, the responsible nurse demonstrates core exercises such as ankle pump exercises and basic walking one-on-one to the patients; at discharge, the key points of home exercise are re-emphasized to patients and their families, and only one telephone follow-up is conducted at 1 month after surgery, without additional exercise reminders, check-in supervision or programme adjustments. The study group receives the combined intervention of evidence-driven computerised rule-guided exercise prescription and closed-loop remote supervision, based on the high-quality rehabilitation evidence systematically searched from Chinese and English databases between January 2020 and December 2025, two rounds of Delphi expert consultation and patient demand interviews. A rule-based computerised clinical decision support system based on a WeChat mini-programme is built. After inputting individual patient data, including age, New York Heart Association cardiac function class, ABI, maximum preoperative walking distance, postoperative wound healing and postoperative recovery stage, the system automatically generates a staged and individualised exercise prescription, which is embedded with a safety constraint threshold alarm mechanism, and all automatically generated prescriptions need to be reviewed and confirmed by clinicians. Th

Interventions

Inclusion criteria

1. Patients who met the diagnostic criteria for LEASO, presented with a Fontaine ischaemia grade of II (intermittent claudication) and had undergone an endovascular intervention or open bypass surgery 2. Aged ≥45 years 3. With a preoperative ABI ranging from 0.4 to 0.9 4. Who were conscious, able to partake in basic communication and able to operate WeChat 5. Whose participation was voluntarily and who were able to complete follow-up

Exclusion criteria

1. Patients with severe cardiac, pulmonary, hepatic or renal dysfunction 2. With a malignant tumour, abnormal coagulation function or active bleeding 3. With a lower extremity deformity or severe osteoarthritis affecting walking 4. With cognitive dysfunction or mental illness 5. Who were unable to cooperate with the intervention or complete data collection 6. With critical limb ischaemia of Fontaine grades III or IV 7. Who withdrew from the study or discontinued the intervention during the research period

Locations

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