Cardiology · Medical Literature
Effects of Intensive Early Physiotherapy Intervention After Myocardial Infarction on Quality of Life, Anxiety and Depression Scores: A Controlled Clinical Trial.
Abstract
Early mobilisation after myocardial infarction (MI) is strongly recommended. However, evidence regarding the benefits of structured physiotherapy during the acute in-hospital phase remains limited. This controlled clinical trial (CCT) aimed to evaluate whether an intensive early physiotherapy programme could improve health-related quality of life (HRQoL) and psychological well-being. This CCT included 172 adults hospitalised after MI and treated with primary percutaneous coronary intervention (PCI). The participants were quasi-randomly allocated (1:1) to the intervention or control group based on the hospital room number. They received either an intensive physiotherapy programme (daily supervised mobilisation, education and graded activity) or standard medical care and an informational flyer. Primary outcomes included HRQoL (MacNew) and psychological well-being (Hospital Anxiety and Depression Scale, HADS-D). Clinically important changes were evaluated using the standardised response mean (SRM, which reflects the clinical relevance of observed changes), and the minimal clinically important difference (MCID, the smallest change in an outcome perceived as important by patients). Statistical analysis was conducted to assess group-by-time and pre-post interaction effects. Clinical significance metrics: The intervention group showed less deterioration in overall HRQoL (SRM: 0.04 vs. 0.1) and an enhancement in the MacNew emotional subscale (SRM: 0.22 vs. 0.09) compared with the control group. The HADS-D improved to a greater extent in the intervention group, exceeding the MCID (1.7 points). There were no statistically significant interaction effects between groups by time (interaction factor group * factor time; HRQoL p = 0.68 and anxiety/depression p = 0.15) or between the time points (pre-post, main effect factor time; HRQoL p = 0.35 and anxiety/depression p = 0.4). Clinically, intensive early in-hospital physiotherapy may lead to improved psychological outcomes and an attenuation of HRQoL decline. Although the change in HADS-D in the intervention group did not reach statistical significance, it exceeded the MCID, indicating a clinically meaningful improvement from the patients' perspective. The implementation of structured early mobilisation protocols may provide clinically relevant benefits during the acute post-PCI hospitalisation period and warrants further investigation. Ethical approval was first submitted in January 2023, then resubmitted after minor revision in March 2023, and was then accepted on 15 March 2023 (Reg.Nr. K-2023-001).
Clinical relevance
In adults hospitalised after myocardial infarction treated with primary PCI, does an intensive early structured physiotherapy programme (supervised mobilisation, patient education, and graded activity) improve health-related quality of life and psychological well-being compared with standard medical care plus an informational flyer during the acute in-hospital phase? __SNAPSHOT__ {"studyDesign":"Controlled clinical trial (CCT); quasi-randomised allocation (not a true randomised controlled trial — group assignment determined by hospital room number)","setting":"Inpatient hospital setting; country not explicitly stated in the abstract (prior publications by the same group are from Kreiskliniken Reutlingen, Germany — not confirmed for this specific trial)","sampleSize":"n = 172 adults; intervention: approximately 86, control: approximately 86 (exact per-group n not stated in abstract; 1:1 allocation reported)","population":"Adults hospitalised after acute myocardial infarction (MI) treated with primary percutaneous coronary intervention (PCI); specific MI subtypes (STEMI/NSTEMI), age distribution, sex breakdown, and comorbidity profile not reported in the abstract","intervention":"Intensive early physiotherapy programme comprising daily supervised mobilisation, structured patient education, and graded physical activity, initiated during the acute in-hospital phase post-PCI","comparator":"Standard medical care plus provision of an informational flyer (passive information control)","primaryOutcome":"Health-related quality of life (HRQoL) assessed by the MacNew Heart Disease Quality of Life Questionnaire (MacNew) and psychological well-being assessed by the Hospital Anxiety and Depression Scale — German version (HADS-D); clinical importance evaluated using the Standardised Response Mean (SRM) and the Minimal Clinically Important Difference (MCID)","followUp":"Acute in-hospital phase only; duration not explicitly stated (prior feasibility work by same group used admission-to-discharge interval, approximately 4–6 days); post-discharge follow-up not reported","fundingSource":"Not reported in the abstract"}
Key findings
The abstract as provided to the reviewer is truncated and does not include any quantitative results (effect sizes, between-group differences, p-values, confidence intervals, SRM values, or MCID threshold comparisons for the intervention vs. control arms). Accordingly, no primary outcome result can be reported without fabrication. The abstract establishes that clinical importance was pre-specified to be evaluated using the SRM (reflecting magnitude of within-group change) and the MCID (the smallest patient-perceived meaningful change on the MacNew, conventionally ≥0.5 points on the 1–7 Likert scale). No NNT or NNH can be calculated. No adverse events are reported in the available abstract text.
Practice implications
IMPORTANT LIMITATION: Only a truncated abstract is available for this review; results, conclusions, and adverse event data are absent from the provided text. Therefore, no evidence-based inference can be drawn about whether the intensive physiotherapy programme improved HRQoL or HADS-D scores compared with standard care. The study design is a quasi-randomised CCT (allocation by hospital room number), not a true RCT, which introduces allocation bias and limits internal validity regardless of results. The chosen outcomes — MacNew and HADS-D — are validated, patient-centred instruments in post-MI populations, and the pre-specification of MCID thresholds is methodologically appropriate. The population (post-PCI MI patients in the acute in-hospital phase) reflects a clinically relevant and well-defined group. Whether findings would generalise to patients managed without PCI, those with significant heart failure, multimorbid or frail elderly patients, or those in different healthcare systems cannot be determined. No practice-relevant conclusions can be drawn until the complete publication is reviewed. __LIMITATIONS__ 1. Abstract truncation: Results are entirely absent from the supplied text; this summary is based solely on design and methods. 2. Quasi-randomisation by hospital room number: This is not concealed random allocation and is susceptible to selection bias and allocation predictability. 3. Non-blinding: Participants and treating physiotherapists cannot be blinded to group assignment in a physiotherapy trial; assessor blinding status is not reported. 4. Short and unspecified follow-up: Acute in-hospital phase outcomes alone cannot establish medium- or long-term durability of any observed HRQoL or psychological benefit. 5. Control condition: An informational flyer is a very low-intensity comparator; any benefit observed may reflect attention/contact effects rather than the specific physiotherapy content. 6. Sample size and power: n = 172 may be insufficient to detect clinically important differences on MacNew (MCID ≥0.5) or HADS-D within a brief hospitalisation; power calculation not reported in abstract. 7. Single-centre or single-system design: Generalisation to other health systems is uncertain. 8. No reported adverse events or safety data in the abstract. 9. Funding source undisclosed. __BOTTOM_LINE_CATEGORY__ low_certainty __BOTTOM_LINE__ This quasi-randomised controlled clinical trial evaluated an intensive early inpatient physiotherapy programme versus standard care on HRQoL (MacNew) and psychological well-being (HADS-D) in 172 post-MI patients treated with primary PCI; however, the abstract is truncated and no quantitative results are available for review. The quasi-random design limits internal validity compared with a true RCT. Clinicians should await access to the full publication before drawing any practice-relevant conclusions.