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. 2026 Aug 1;31(4):e70305. doi: 10.1002/pri.70305

Effects of Intensive Early Physiotherapy Intervention After Myocardial Infarction on Quality of Life, Anxiety and Depression Scores: A Controlled Clinical Trial

Kinga Balla 1,✉, Karl K Haase 2, Alexander Wick 2
PMCID: PMC13428498  PMID: 42541455

ABSTRACT

Background and Purpose

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.

Methods

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.

Results

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).

Discussion

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.

Trail Registration

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)

Keywords: acute myocardial infarction, anxiety and depression, physiotherapy, quality of life

1. Introduction

Myocardial infarction (MI) remains a major cause of morbidity and mortality worldwide (Cardiovascular diseases (CVDs) 2025; Salari et al. 2023). Advances in acute coronary care and revascularisation strategies have substantially improved survival rates after MI. Despite these improvements, many patients experience a marked decline in health‐related quality of life (HRQoL) during the early post‐MI period. This decline is frequently accompanied by symptoms of anxiety and depression (Dixon et al. 2002; Hosseini et al. 2014; Kang et al. 2018; Rafael et al. 2014). Impaired psychological well‐being has been associated with delayed functional recovery, reduced adherence to medical treatment and lifestyle recommendations and poorer clinical outcomes (Freene et al. 2024; van Melle et al. 2005). These findings underline the importance of early interventions aimed at supporting both physical function and mental health during hospitalisation. Exercise‐based cardiac rehabilitation (CR) has consistently been shown to improve physical fitness, HRQoL and psychological well‐being (Anderson et al. 2016). However, conventional CR programmes are generally initiated several weeks after hospital discharge, leaving the acute post‐MI period relatively underrepresented in rehabilitation strategies. The in‐hospital phase represents a critical therapeutic window in which early mobilisation may prevent physical deconditioning and mitigate psychological distress (Haykowsky et al. 2011). Physiotherapy interventions delivered during hospitalisation may further promote recovery by enhancing self‐efficacy and reducing anxiety through patient education, supervised physical activity and structured behavioural support (Ryan et al. 1999).

Although early physical activity following MI is recommended by international guidelines, current recommendations provide only limited and sometimes inconsistent guidance regarding the timing, intensity and content of early mobilisation interventions, leaving clinicians without a clearly defined evidence‐based protocol. Only a limited number of recent studies have investigated structured physiotherapy during the immediate post‐MI period. The interventions evaluated in these studies varied considerably in their design and content. In addition, some studies have been based on outdated rehabilitation approaches. To address this gap, we implemented the Reutlingen Myocardial Infarction Therapy Model (RMTM), an evidence‐based physiotherapy concept specifically developed for the acute in‐hospital rehabilitation phase following MI (Balla and Haase 2024a, 2024b).

This controlled clinical trial (CCT) aims to investigate whether an intensive early physiotherapy programme during the in‐hospital phase after MI could improve HRQoL and psychological well‐being compared with standard care. Specifically, we examine whether patients receiving structured physiotherapy show less deterioration in HRQoL and greater reductions in anxiety and depressive symptoms from baseline to post‐intervention than patients receiving standard care. Accordingly, we hypothesise that (i) HRQoL declines after MI in both groups but that the decline is less pronounced in the intervention group and that (ii) anxiety and depression scores improve more substantially in the intervention group than in the control group.

2. Methods

2.1. Study Design

This single‐centre CCT was conducted at Kreiskliniken Reutlingen, Germany between April 2023 and March 2025. The participants were allocated at a 1:1 ratio to either the intervention or control group using a quasi‐random allocation procedure based on even and odd hospital room numbers. The study employed an open‐label design. Owing to the nature of the intervention, neither participants nor physiotherapists could be fully blinded to the treatment allocation. The investigator, responsible for participant enrolment and group assignment, was also not blinded. Ethical approval was obtained from the institutional research ethics committee prior to recruitment (Reg. No. K‐2023‐001, date of approval 15.03.2023). The study was conducted in accordance with the principles of the Helsinki Declaration. The participants were informed that enrolment was voluntary and that they could withdraw from the study at any time. Written informed consent was obtained from all enrolled individuals.

Potential participants were screened and identified by physicians in the intensive care unit, intermediate care unit and cardiology ward at Kreiskliniken Reutlingen, according to predefined eligibility criteria. The eligible participants were adults hospitalised with acute MI who had undergone percutaneous coronary intervention (PCI). The exclusion criteria included conservatively managed MI, palliative care status, significant language barriers, cognitive impairment or dementia, immobility and isolation due to an acute infectious disease. Participation was voluntary, and all eligible patients were invited to participate in the study.

The intervention group received a structured early physiotherapy intervention based on the ‘Reutlingen Myocardial Infarction Therapy Model’ (RMTM, Balla and Haase 2024a, 2024b) for up to 6 days (mean 3.6; SD 1.4 days). A detailed description of the intervention protocol is provided in the supplementary materials (Figure S1). Briefly, the programme combines a graded progression in cardiovascular activity with structured patient education on safe behaviour and physical activity following MI. The mobilisation protocol comprises three consecutive 2‐day stages beginning on the day of PCI. Depending on the stage, therapeutic activities include chair‐based exercises, hallway walking, cycle ergometer training and stair climbing. Each treatment session lasts 45 min, including patient education. Progression within a stage is achieved through increases in exercise repetitions and/or exercise complexity while maintaining the overall session duration. This advancement is guided by predefined clinical criteria, including haemodynamic stability, symptom tolerance and perceived exertion, and is supervised by a physiotherapist specialised in cardiac rehabilitation. Progression is permitted only if the preceding session is completed without adverse events and within the predefined safety limits of the RMTM. Advancement between stages follows the predetermined structure of the RMTM. At each stage, physiotherapists assess and document physiological and functional parameters at rest, immediately after exercise and 3 min post‐exercise. Measurements include blood pressure, heart rate, oxygen saturation, respiratory rate and subjective exertion assessed using the Rate of Perceived Exertion (RPE) and the Borg Dyspnoea Scale (Borg 1982).

Regarding intervention adherence in the intervention group, 37 patients completed all three stages, and 47 completed two stages, primarily due to missed Stage I following weekend admission or public holidays. Two patients completed only Stage II (2 days) due to early discharge; in these cases, the 6‐min walk test (6MWT) was performed on day 4 after consultation with the treating physician. Intervention fidelity was partially constrained by the absence of weekend physiotherapy services. Interim basic mobilisation was provided by nursing staff familiar with the protocol.

The participants in the control group received standard medical care supplemented with an informational flyer on MI, covering causes, symptoms, contraindications and general recommendations. Practical physiotherapy guidance or structured patient education was not provided.

On the day of discharge, both groups performed the 6 MWT (Kammin 2022), a widely used, simple, low‐cost and validated submaximal exercise test, under physiotherapeutic supervision. The test was conducted in a 30‐m‐long, straight, hard‐surfaced and enclosed corridor. The participants were instructed to avoid vigorous physical activity for at least 2 h prior to testing whenever possible. Standardised instruction was given to all the participants, asking them ‘to walk as far as possible within 6 minutes’ while allowing them to self‐select their walking pace.

2.2. Outcomes

The primary outcomes were quality of life, measured with the MacNew questionnaire, and symptoms of anxiety and depression, assessed using the Hospital Anxiety and Depression Scale (HADS‐D). Both outcomes were analysed in a pre–post comparison. The secondary outcome was functional capacity, which was evaluated using the 6MWT.

2.3. Materials

The German version of the MacNew Heart Disease Quality of Life Questionnaire (Dixon et al. 2002; Höfer et al. 2016) and the HADS‐D (Herrmann‐Lingen et al. 2018) were used to assess HRQoL, anxiety and depression. Licence agreements were obtained for both instruments. The MacNew questionnaire comprises 27 items that assess three interrelated domains of well‐being: emotional, physical and social. Domain scores are calculated as the mean of the corresponding items, and a global HRQoL score is derived by averaging all 27 items. Items are answered independently on a seven‐point Likert scale (1‐7), with higher scores indicating better HRQoL. Missing values do not contribute to scale scores; domain scores are not calculated if fewer than half of the relevant items are completed. Values 1‐4 indicate poor HRQoL, values 4‐6 represent moderate HRQoL, and values above 6 reflect above‐average HRQoL.

The HADS‐D is a brief, self‐administered instrument designed to screen for symptoms of anxiety and depression, specifically in cardiovascular patients (Herrmann‐Lingen et al. 2018). It includes 14 items (seven for each subscale, anxiety and depression, in alternating order) with four response options (0–3), yielding possible subscale scores ranging from 0 to 21. Scores are interpreted as normal (≤ 7), borderline (8–10), severe (11–14) and very severe (15–21).

The questionnaires were completed independently by the participants on the first day of treatment (approximately 15 min) and again on the day of discharge. At baseline, the patients were instructed to answer the items with reference to the week preceding their PCI. At discharge, the responses were referred to the week of hospitalisation following PCI.

2.4. Subjects

The flow diagram in Figure 1 presents the numbers of participants who were allocated, who received the intended intervention and who were analysed for the primary outcome, as well as the losses and exclusions after inclusion. Patients who discontinued participation were excluded from the final analysis.

FIGURE 1.

FIGURE 1

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Participant flow diagram.

Baseline demographic and clinical characteristics were comparable between the two groups (Table 1).

TABLE 1.

Demographic description of patients.

Demographic description Intervention group, N = 86 Control group, N = 86
Age 61.55 (SD 10.3) 63.01 (SD 12.01)
Gender
Female 26.7% 24.4%
Male 73.3% 75.6%
Diverse 0% 0%
Diagnosis
NSTEMI 46.5% 52.3%
STEMI 53,5% 47.7%
Hospitalisation (Day) 6.0 ± 1.9 6.0 ± 2.6
Arterial hypertension
yes 77.9% 80.2%
no 22.1% 19.8%
Lipid metabolism disorder
yes 58.1% 56.5%
no 41.9% 43.5%
Positive family history
yes 48.8% 62.8%
no 51.2% 37.2%
Diabetes
yes 26.7% 20.9%
no 73.3% 79.1%
Smoking
no, never or > 2 years 68.6% 66.3%
no, since MI 18.6% 16.7%
yes, still 12.8% 7.0%
BMI
Normal weight BMI 18.5–24.9 22.6% 29.8%
Overweight BMI 25–25.9 50% 46.4%
Obesity 1 BMI 30–34.9 16.7% 16.7%
Obesity 2 BMI 35–39.9 7.1% 4.8%
Obesity 3 BMI > 40 3.6% 2.3%
LV function
Normal LV 44.2% 51.2%
Mild reduced LV 30.2% 26.2%
Moderate reduced LV 16.3% 16.7%
Severe reduced LV 9.3% 5.9%
Stress a
yes 37.9% 45.3%
no 62.1% 54.7%
Sport b
yes 55.8% 57.0%
no 44.2% 43.0%
MI previously
yes 12.8% 12.8%
no 87.2% 87.2%
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Abbreviations: BMI = body mass index; LV = left ventricular pump function; MI = myocardial infarction; NSTEMI = non‐ST‐elevation myocardial infarction; STEMI = ST‐elevation myocardial infarction.

a

defined as self‐reported regular psychological stress (occupational or personal).

b

defined as self‐reported regular physical activity performed ≥ 2 per week.

2.5. Statistics

The required sample size was calculated using G*Power3.1.9.7 (G*Power, n.d.), assuming a statistical power of 80%, an alpha level of 5% and an expected effect size of 0.2, resulting in a target sample size of 168 participants. To account for potential attrition, 172 patients were recruited. Inferential testing constituted the primary analysis for which the study was powered. The minimal clinically important difference (MCID) and standardised response mean (SRM) were applied as pre‐specified complementary indicators of clinical relevance and were not intended to replace inferential statistical significance testing. Clinical significance was assessed using the SRM and MCID to interpret the results. The SRM is an effect size index used to assess the responsiveness of quality of life and anxiety/depression scales to clinical change over time (clinically important change). It is calculated as the mean change in scores between the baseline and follow‐up, divided by the standard deviation of the individual change scores, with larger absolute values indicating greater responsiveness (Dixon et al. 2002). Conventionally, SRM values are interpreted as follows: < 0.20 trivial, 0.20–0.50 small, 0.50–0.80 moderate and > 0.80 large effects. Furthermore, the MCID was applied, defined as 0.5 points on the MacNew seven‐point scale and 1.7 points for the HADS, representing the smallest changes considered clinically meaningful (Höfer et al. 2016; Lemay et al. 2019). Inferential statistical analyses were performed using SPSS (Version 31.0.0.0‐117, IBM SPSS Statistics 31, 2025) by applying mixed ANOVA procedures with the level of significance set at p = 0.05. Descriptive statistics, including the means, standard deviations (SD), 95% confidence intervals and percentages, were utilised to present the sample characteristics. Data were analysed on a complete‐case basis. The participants without a complete pre‐ and post‐intervention dataset (e.g., due to early discharge or withdrawal of consent) were excluded from the final analysis, and no imputation of missing values was performed. The statistical analysis was conducted in collaboration with a biostatistician (Dr. Pumptow, Department of Clinical Epidemiology and Applied Biometrics, Tübingen, Germany).

3. Results

3.1. Inferential Statistic

Figure 2 shows the potential associations between temporal changes and group assignment (group‐by‐time interaction; HRQoL p = 0.68 and anxiety/depression p = 0.15). In addition, no significant differences were observed between the time points (pre‐post comparison, main effect factor time; HRQoL p = 0.35 and anxiety/depression p = 0.4).

FIGURE 2.

FIGURE 2

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Inferential analysis of MacNew and HADS‐D scores: group‐by‐time interaction and pre‐post comparison. 95% CI = 95% confidence intervals; SD = standard deviation. MacNew baseline intervention group: 5.5 (SD 1.0), 95% CI: 5.3–5.7. MacNew baseline control group: 5.36 (SD 1.1), 95% CI: 5.13–5.59. MacNew discharge intervention group: 5.44 (SD 1.0), 95% CI: 5.22–5.66. MacNew discharge control group: 5.26 (SD 1.1), 95% CI: 5.03–5.49. HADS‐D baseline control group: 10.68 (SD 7.8), 95% CI: 9.0–12.36. HADS‐D baseline intervention group: 10.0 (SD 7.5), 95% CI: 8.4–11.6. HADS‐D discharge control group: 9.0 (SD 8.2), 95% CI: 7.25–10.77. HADS‐D discharge intervention group: 7.7 (SD 6.4), 95% CI: 6.35–9.11.

3.2. Clinical Significance

When analysing the three MacNew domains separately, the emotional domain showed an improvement from baseline to discharge, whereas the physical and social domains declined in both groups. The improvement in the emotional domain was more pronounced in the intervention group (Figure 3), corresponding to a small standardised response mean (SRM = 0.22), while the control group showed no relevant change (SRM = 0.09).

FIGURE 3.

FIGURE 3

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Comparison of the MacNew emotional domain scores between the intervention and control groups. 95% CI = 95% confidence intervals; MI = myocardial infarction; SD = standard deviation. MacNew baseline intervention group: 5.24 (SD 1.0), 95% CI: 5.03–5.45. MacNew baseline control group: 5.15 (SD 1.1), 95% CI: 4.9–5.4. MacNew discharge intervention group: 5.42 (SD 1.1), 95% CI: 5.19‐5.65. MacNew discharge control group: 5.28 (SD 1.2), 95% CI: 5.03–5.53.

According to the HADS‐D, the intervention group showed a clinically meaningful improvement, with a mean change of 2.31 points, exceeding the established MCID of 1.7 points. By contrast, the control group improved by 1.67 points, which was slightly below the MCID threshold.

3.3. Functional Capacity

The intervention group achieved a mean walking distance of 446.4 m (SD 78.4) in the 6MWT assessed at discharge without a baseline measurement, which was 20 m (4.5%) greater than that of the control group (426.2 m, SD 111.8). These differences are presented in detail in Table 2. No adverse events occurred in either group. As this comparison is descriptive and not inferential, the observed between‐group difference should be interpreted as an indicator of the overall functional trend rather than as a statistically tested intervention effect.

TABLE 2.

Descriptive comparison of the 6‐minute walk test.

Descriptive statistics Intervention group, N = 86 Control group, N = 86
Therapy days (mean) 3.6 (SD 1.4) —
6 MWT results (metre) 446.4 (SD 78.4) 426.23 (SD 111.8)
Borg Dyspnoea before 6MWT 0.03 (SD 0.2) 0.3 (SD 1.1)
Rate of perceived exertion before 6MWT 6.0 (SD 0.0) 6.1 (SD 0.7)
Borg Dyspnoea after 6MWT 2.55 (SD 1.7) 1.93 (SD 2.0)
Rate of perceived exertion after 6MWT 8.6 (SD 2.3) 8.33 (SD 2.2)
Mean value of days on which 6 MWT was performed 5.6 (SD 1.7) 5.6 (SD 1.9)
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Abbreviations: 6MWT = 6‐minute walk test; M = Metre; SD = standard deviation.

International reference data were used to contextualise the functional capacity results of our cohort (Table 3). At discharge, the 6MWT distances observed in both study groups were similar to or in some cases slightly higher than those reported in comparable post‐MI cohort studies (Dickens et al. 2006; Freene et al. 2024; Herrmann‐Lingen et al. 2018; Hinz and Brähler 2011; Höfer et al. 2016; Kang et al. 2021). As these comparisons are descriptive and based on cohorts assessed under different clinical conditions, they should be interpreted with caution. Overall, the findings suggest that patients in the present study had functional performance generally within the range of previously published reference values, although a direct comparison was limited by differences in cohorts and testing conditions.

TABLE 3.

Comparison of 6‐minute walk test results assessed at discharge with international data from similar studies.

Our study: intervention group Our study: control group Qu et al. (2021) Diniz et al. (2017) Matos‐Garcia et al. (2017) Peixoto et al. (2015) Ferreira et al. (2015) Healthy adults Cazzoletti et al. (2022)
N 86 86 41 152 54 88 30 530
Age 61.5 (SD 10.3) 63.0 (SD 12.1) 56.8 (SD 9.5) 55.7 (SD 9.7) 55.8 (SD 11.0) 56.0 (SD 9.6) 58.5 (SD 13.4) 46.8 (SD 11.8)
Gender
Male N = 63 N = 65 N = 27 N = 117 N = 39 N = 62 N = 9 N = 243
Female N = 23 N = 21 N = 14 N = 77 N = 15 N = 26 N = 21 N = 287
Distance in meter 446.4 (SD 78.4) 426.2 (SD 111.8) 256.18 (SD 26.8) 442.4 (SD 75.2) 465.1 (SD 67.8) 436.3 (SD 82.3) 295.9 (SD 81.6) 595.0 (SD 73.3)
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Abbreviation: SD = standard deviation.

4. Discussion

In this CCT, an intensified early physiotherapy intervention during the acute in‐hospital phase after MI was associated with favourable trends in psychological outcomes and functional performance compared with standard care. Although global HRQoL declined in both groups, consistent with the expected pattern during early hospitalisation, the intervention group showed a more positive trajectory in the emotional domain of the MacNew and a clinically meaningful reduction in HADS‐D scores. Although these between‐group effects did not reach statistical significance, they suggest a potentially relevant clinical benefit and warrant further investigation.

Most research on post‐MI rehabilitation has focused on phase II cardiac rehabilitation, which typically begins several weeks after discharge and emphasises structured outpatient exercise programmes (Tessler and Bruno 2023; Zhang et al. 2018). By contrast, only a limited number of studies have investigated physiotherapy interventions during the acute in‐hospital phase after MI, and these studies have employed heterogeneous approaches (Ul‐Haq et al. 2019; Schon et al. 2024; Copotoiu et al. 2020). Evidence regarding HRQoL and psychological outcomes during this early recovery period remains particularly scarce (Freene et al. 2024; Peixoto et al. 2015). To our knowledge, this is the first study to evaluate the effect of early in‐hospital physiotherapy on psychological well‐being using both the MacNew and HADS‐D in a pre–post design.

As expected, overall HRQoL deteriorated during the initial post‐MI period, with the most pronounced declines observed in the physical and social domains (Balla and Haase 2024a, 2024b). This finding likely reflects the restricted mobility, physical limitations and reduced social participation that characterise early hospitalisation. Conversely, emotional HRQoL improved in both groups, with a more marked enhancement in the intervention group. These observations may indicate that moderately supervised physical activity and structured patient education delivered by physiotherapists could be associated with reduced emotional distress. Even the control group, which had only minimal physiotherapy contact (e.g., informational flyer distribution and participation in the 6MWT), showed a slight improvement in emotional well‐being, suggesting that even limited guided interaction may provide reassurance during the acute phase. However, these trends should be considered observational in nature and require further examination rather than being interpreted as evidence of demonstrated treatment efficacy.

A similar pattern was observed for anxiety and depression symptoms. Although no statistically significant between‐group differences were detected, the reduction in HADS‐D scores in the intervention group exceeded the MCID, indicating a potentially meaningful improvement from the patient's perspective. As highlighted by Lemay Kyle et al., statistical significance should not be equated with clinical relevance (Lemay et al. 2019). The MCID for the HADS‐D serves as an indicator of therapeutic success and may help guide future clinical interventions targeting improvements in patients' mental health. Compared with national and international reference data (Dickens et al. 2006; Herrmann‐Lingen et al. 2018; Hinz and Brähler 2011), the participants in the present study showed generally favourable levels of anxiety and depression during the first week after MI. This pattern may suggest that supervised activity, structured information and self‐assessment training delivered by physiotherapists could be associated with the stabilisation of psychological outcomes in the early phase of recovery. Thus, these exploratory findings justify further evaluation.

Previous studies have shown that symptoms of depression and anxiety are strongly associated with reduced HRQoL after MI (Hosseini et al. 2014; Kang et al. 2021; Rafael et al. 2014). The immediate post‐MI period is typically characterised by elevated psychological distress, making the in‐hospital phase an important window for early supportive intervention. In the present study, both groups experienced reductions in anxiety and depressive symptoms by the time of discharge. However, these improvements were not sufficient to counteract the expected early decline in overall HRQoL during hospitalisation.

In the 6MWT group, patients in the intervention group achieved a mean walking distance of 446 m, representing a functional capacity comparable to or slightly above the values reported in international post‐MI cohorts (Freene et al. 2024; Höfer et al. 2016; Qu et al. 2021; Ul‐Haq et al. 2019). Although direct comparisons must be interpreted with caution due to differences in patient populations and assessment protocols, the structured early mobilisation including increased walking load, supervised activity, and systematic progression from standing to stair climbing may have contributed to the favourable functional performance observed at discharge.

4.1. Limitations

This study has several limitations. First, it was a single‐centre, quasi‐randomised, open‐label trial without blinding of the patients or therapists, which could limit predictability and generalisability and may introduce performance bias. True randomisation was not applied to avoid placing the intervention and control patients in the same room, which could lead to contamination through observation and imitation of exercises and educational content. Nevertheless, some degree of contamination between the groups could not be fully excluded. Second, the analyses were performed on a complete‐case basis rather than an intention‐to‐treat basis. Patients discharged early or who withdrew their consent were excluded, which could have introduced attrition bias. Third, no baseline 6MWT was obtained (according to American Thoracic Society guidelines, the 6MWT is contraindicated ≤ 3 days after MI); thus, the discharge difference could not be attributed to the intervention. Fourth, the trial was not prospectively registered in a public clinical trial registry. Fifth, the short in‐hospital observation period allowed for only immediate pre‐post assessment, and no long‐term follow‐up was conducted. Thus, the sustainability of the observed effects remains unknown. Sixth, the study was not powered for subgroup analyses, and no multivariable adjustment was performed. Therefore, residual confounding due to factors such as cardiac function, comorbidities (e.g., diabetes mellitus) and baseline physical activity levels cannot be excluded and may have influenced psychological and health‐related quality‐of‐life outcomes independently of the intervention. Finally, comparisons with international reference data were descriptive only, as the differences in patient populations and testing conditions precluded inferential interpretation.

5. Implications for Physiotherapy Practice

In this CCT, an intensified early physiotherapy programme during the acute in‐hospital phase after MI was associated with statistically non‐significant but clinically relevant trends towards improved psychological outcomes compared with standard care. Patients receiving structured daily mobilisation and physiotherapist‐guided education showed a more positive clinical trajectory in emotional well‐being and achieved clinically meaningful reductions in anxiety and depression. Although overall HRQoL declined as expected during hospitalisation, these preliminary patterns suggest that early physiotherapy may support psychological stabilisation and functional recovery in the immediate post‐MI period. However, these observations should be interpreted as exploratory. Further multicentre studies with long‐term follow‐up are needed to determine the sustained impact of early physiotherapy on post‐MI rehabilitation trajectories.

Funding

This research was funded by the Kreiskliniken Reutlingen gGmbH, Germany.

Ethics Statement

Ethical approval was obtained from the institutional research ethics committee before recruitment. The study was conducted in accordance with the principles set forth in the Helsinki Declaration.

Consent

All the enrolled patients signed an informed consent before participation.

Conflicts of Interest

The authors declare no conflicts of interest.

Permission to Reproduce Material From Other Sources

The authors have nothing to report.

Supporting information

Figure S1: Effects of intensive early physiotherapy intervention after myocardial infarction on quality of life, anxiety and depression scores.

PRI-31-e70305-s001.jpg (208.3KB, jpg)

Acknowledgements

The authors would like to acknowledge Nadja Chalamanova for supporting this study as the department head and Dr. Pumptow for her valuable statistical advice and support.

Data Availability Statement

The data generated and analysed in this study are available from the corresponding author upon reasonable request.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Figure S1: Effects of intensive early physiotherapy intervention after myocardial infarction on quality of life, anxiety and depression scores.

PRI-31-e70305-s001.jpg (208.3KB, jpg)

Data Availability Statement

The data generated and analysed in this study are available from the corresponding author upon reasonable request.

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