Erdman 1986.
Methods |
Study design: Single centre RCT Country: Netherlands Dates patients recruited: September 1976 to March 1978 Maximum follow up: 5 years |
|
Participants |
Inclusion criteria: First MI within 6 months before the first psychological investigation; <65 years; meet three psychological inclusion criteria ‐ one or more symptoms of the anxiety reaction, diminished self‐esteem, positive motivation to take part in the programme. Exclusion criteria: Severe cardiomyopathy, severe valvular disorders, inadequate performance on exercise, unstable angina pectoris. N Randomised: total: 80; intervention: 40; comparator: 40 Diagnosis (% of pts): MI: 100 % Age (years): 51 years (range 35‐60 years); intervention: NR; comparator: NR Percentage male: intervention: 100%; comparator: 100% Ethnicity: NR |
|
Interventions |
Intervention: Two 1½ hour sessions of fitness training a week in a conventional gymnasium, supervised by a cardiologist. Each session consisted of a 15 min warm up, gymnastics and jogging (both 15 min); sport such as volleyball, soccer and hockey (30 min) and relation exercises (15 min). Components: exercise and education. Setting: supervised group sessions in centre. Aerobic exercise: Modality: gymnastics, jogging and team sports. Length of session: 90 min. Frequency: twice a week. Intensity: NR Resistance training included? No. Total duration: 6 months. Co‐interventions: in cases of severe psychopathology, a psychologist or a psychiatrist was consulted. Comparator: Home rehabilitation‐ patients received an educational brochure with guidelines and advice about physical fitness training and jogging. Co‐interventions: Treatment with either beta blockers or anticoagulants was given upon indication only and not as a prophylactic measure. |
|
Outcomes | Mortality, non fatal MI at 5 years. | |
Source of funding | Dutch Heart Foundation. | |
Conflicts of interest | NR | |
Notes | Complex presentation of results. Authors conclude that patients who will benefit from rehab can be detected on psychological grounds. Those who have engaged in habitual exercise, but feel seriously disabled, yet do not feel inhibited in a group will benefit from rehab. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomly allocated by means of a table for random numbers". |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 29 % lost to follow up, no description of withdrawals or dropouts. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported at all time points. |
Groups balanced at baseline | Low risk | “There were no differences between the study groups in terms of prior stressful life‐events”. No other baseline measures are reported. |
Intention‐to‐treat analysis conducted | High risk | No. |
Groups received same treatment (apart from the intervention) | Low risk | “The rehab program consists of two 1 ½ hour sessions of fitness training a week in a conventional gym, supervised by a cardiologist. The multidisciplinary team is composed of two physiotherapists, a social worker and a nurse. In cases of severe psychopathology, a psychologist or a psychiatrist was consulted…”. “Both groups received the usual outpatient cardiologic care.“ |