Lin 2004.
Study characteristics | ||
Methods |
Study design: parallel‐group randomised controlled trial No of centres: 1 Country: China Dates patients recruited: NR When randomised: NR Maximum follow‐up (from baseline): 3 months |
|
Participants |
Inclusion criteria: 20 to 45 years of age who have undergone single or double heart valve replacement Exclusion criteria: comorbidities including pathological changes associated with coronary arteries, reoperations for valve replacement surgeries (patients who have undergone valve replacement before), severe pathological changes associated with other organs N Randomised: total: 104; intervention: 55; comparator: 49 Number of participants lost to follow‐up: 7 Number of dropouts: 3 (2 due to irregular heart rhythm, 1 for delayed pericardial tamponade) Number with complications: 4 (rehabilitation group: 1 sudden death, 1 brain stem disease; control group: 1 paravalvular leakage, 1 endocarditis) Diagnosis (% of pts): e.g. Aetiology: the kind of valve disease is not specified; we assume that all kinds of valve diseases are included Kind of surgery: mechanical valve replacement of any kind NYHA: NR LVEF: NR Case mix: NR Age (mean ± SD): total: NR; intervention: 32.8 ± 12.1;comparator: 29.8 ± 9.4 Percentage male: total: 56.73%; intervention: 56.36%;comparator: 57.14% Ethnicity: NR |
|
Interventions |
Intervention (exercise‐based CR) Description Type of rehabilitation programme: combined physical exercise, breathing exercises, and psychological intervention Setting: hospital‐based and home‐based. At hospital and at home before and after surgery Time after hospitalisation: the day after surgery, and continuing until 3 months after surgery Total duration: starting the week before surgery with breathing exercises and psychological intervention, and the day after surgery with physical exercise
Conducted before surgery, to prevent anxiety and mental pressure before surgery. Introduction to the surgery in detail, and information about safety of the surgery
Conducted before and after surgery Frequency and duration: 2 times a day 1 week before surgery and after surgery Before surgery Breathing exercises: lie down or sit up, pillow under knees, relax muscles in stomach, breathe in through the nose so stomach puffs up, breathe out through the nose. 10 to 12 times per minute. Patients monitor themselves Coughing exercises: after deep breath, use chest and stomach power to cough as much as possible, 2 times daily, 20 times each session, the week before surgery. Breathing machine (Sherwood Voldyne) controls frequency. The patient can look over the results during exercises. Exercises are to be performed both sitting up and half lying down After surgery Day 1: stomach breathing exercise, coughing exercise to get rid of mucus, half lying down, relaxing whole body Day 2: both breathing and coughing exercises
Conducted after surgery. Includes limb stretch/joint exercises and aerobic exercises Frequency: limb stretch/joint exercises: patients were advised to do this whenever they felt like it at home; aerobic exercise 2 to 3 times per week Duration: 3 to 5 minutes limb stretch/joint exercises and 20 to 30 minutes aerobic exercise/session Purpose: the purpose of the training is to increase endurance and increase pulmonary and cardiac capacity At hospital (after surgery) Day 2: joint exercises with passive arms and switch exercises Day 3: joint exercises including both arm and leg exercises Day 4: going out of the hospital, sitting, standing, getting out of bed, walking exercises. Aerobic exercises At home (after discharge) Resistance training: stretch arms and legs 3 to 5 minutes equivalent to 5 to 7 metabolic equivalents (METs) each session. Patients were encouraged to do the exercises whenever possible. The purpose of the exercises was to increase joint mobility, warm up the body, and relieve chest pressure Aerobic exercise: consisted of walking slowly uphill, using treadmill or exercise bike at home. Goal of 5 to 7 METs per session Intensity: not reported Modality: not relevant Both groups: follow regular principles and normal procedure for surgery. During surgery, the same equipment is used for all patients. After surgery, all patients receive the same quantities of analgesics, antibiotics, and anticoagulants Comparator Description: usual care by the hospital's heart doctor Co‐interventions: NR |
|
Outcomes |
Outcomes (scale measured in) Postoperative incidence of pulmonary complications after surgery: measured once in all patients in % of control group and rehabilitation group, respectively, during the 3‐month period Duration of hospitalisation for surgery: days of hospitalisation calculated once after all patients have been discharged after surgery. The number of days between groups was compared Body activity energy level: measured at baseline and after 3 months in METs spent, using low strenuous physical exercises to test pulmonary and cardiac capacity Besides outcome measurement, the purpose of the test was to determine for which patients the exercise could include potential risk and thus tailor the exercise plan in the most appropriate way Other outcomes measured |
|
Notes | Follow‐up: 3 months from procedure First author involved in patient selection, not in randomisation. Study authors emphasise that cardiac rehabilitation including physical exercise should be tailored and concrete, based on different patients' needs, and adjusted if necessary |