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Received date: 23/10/2024 Published date: 14/11/2024 Research Article

Feasibility Indicators in the Analysis of Quality of Life and Depression/Anxiety Scores in Patients after Myocardial Infarction and Percutaneous Coronary Intervention Under Physiotherapeutic Treatment – Qualitative Study

Kinga Balla, PhD*, Karl Konstantin Haase Prof. Dr.

Kreiskliniken Reutlingen G mbH, Steinenberg Str 31,72764 Reutlingen, Germany.

*Corresponding author

*Kinga Balla, Steinenberg Str 31, 72764 Reutlingen, Germany.

DOI: 10.55920/JCRMHS.2024.08.001347

Abstract

Purpose: The aim of this study was to examine the feasibility of implementing a study design investigating the effects of physiotherapeutic treatment in the acute myocardial infarction (MI) phase.

Methods: Seventy-seven patients with acute MI who underwent PCI were asked to participate in the study voluntarily. The MI mobilization plan consisted of three stages; each stage lasted two days, starting with the PCI day. The patients completed the questionnaires (MacNew Heart Disease Quality of Life Questionnaire and Hospital Anxiety and Depression Scale (HADS-D)) independently on the first day of treatment and the day of discharge. The expected outcome was the study design’s feasibility in practice.

Results: Fifty from 72 enrolled patients (69.4%) completed the study. The data collection was successful, no participant had to be excluded. The study was planned for six months, but was extended to 9 months to reach the target sample size (n=50). 72% of the patients have already been encountered in the first stage of MI mobilization plan. The participant’s acceptability showed an average of 1.6 (SD 1.0) on a scale of 0-10, lower score indicating higher satisfaction.

Conclusion: The feasibility of the study methods was confirmed with the recruitment, retention rates, and accuracy of data collection, and that of the program with the participant’s acceptability.

Keywords: Myocardial Infarction; Physiotherapy; Quality of Life; Anxiety; Depression

Introduction

Feasibility studies receive hardly attention in the scientific research field (1), although in some of the studies it would make sense to assess the feasibility of methods and procedures (2–5).

The UK National Institute for Health Research (NIHR (6,7)) developed a definition of feasibility studies: “Feasibility studies are pieces of research done before a main study in order to answer the question ´can this study be done?´ They are used to estimate important parameters that are needed to design the main study” (8).

Pfledderer et al. (9) advocates carrying out a feasibility study, arguing that: “ …feasibility studies play an essential role in the process of conducting larger scale clinical trials by providing information about the potential efficacy and feasibility of an intervention and addressing uncertainties around conducting a larger scale study.”

Bowen et al. (10) describe the rational for performing a feasibility study with the following key areas and possible outcomes: implementation (success or failure of execution), practicality (factors affecting implementation ease or difficulty), integration (perceived fit with infrastructure), expansion (costs to organization and policy bodies), acceptability (satisfaction), demand (perceived positive or negative effects on organization), limited efficacy (effect size estimation) and adaptation (degree to which similar outcomes are obtained in new format). Rogan et al. (11) emphasizes that it is important to establish the criteria of success and present them as the primary endpoint such as: process (determining recruitment rates, retention rates etc.), resources (assessing time and budget problems), management (human and data optimization problems) and scientific (estimation of treatment effect and safety).

Purpose: The main goal of this study was to probe the feasibility of implementing a randomized control study that examines the effectiveness of physiotherapy in the acute MI phase (according to NIHR (7) feasibility studies may or may not be randomized). The questions to be investigated by the target study are whether a difference between the therapy group (daily physiotherapy, education with MI flyer and 6-minute walk test (6 MWT) on the day of discharge) and the control group (hand out MI flyers without personal education or daily physiotherapy and 6 MWT on the day of discharge) on the quality of life and in functional capacity exists. The period of our investigation is within the first and most vital phase of cardiac rehabilitation (12). Haykowsky et al. (13) conducted a meta-analysis and found that delaying the start of training leads to a poorer baseline situation in terms of left ventricular function. This confirms the need for daily therapy immediately after MI (14,15). Ryan et al. (16) described that the early start of exercise training and education about the rules of conduct in everyday life has a stress-reducing and behavior-modifying effect, leading to a better quality-of-life score. Increasing the quality of life of MI patients is a general goal of medical measures. The health-related quality of life (HRQoL) is an essential assessment parameter for the effectiveness of therapeutic services in clinical-cardiological research (17,18).

Material and methods

Participants

Patients with acute MI (NSTEMI, non-ST-elevation myocardial infarction; AW STEMI, anterior wall ST-elevation myocardial infarction; PW STEMI, posterior wall ST-elevation myocardial infarction) with PCI took part in the study voluntarily. The inclusion criteria were acute MI with PCI. The exclusion criteria were MI with conservative therapy, palliative patients, language barrier, patients with dementia or immobility, and isolated patients with acute infection. Ethical approval was obtained from the Ethics Committee of the Hospital Kreiskliniken Reutlingen GmbH before recruitment. The participants were informed that they could withdraw from the study at any time. All the enrolled patients signed an informed consent before participation.

Methods

The study methods were originally described elsewhere (19). The methods description partly reproduces their wording, see also supplementary materials. Briefly, the physiotherapeutic treatment in phase I in Kreiskliniken Reutlingen GmbH, Germany, includes the dose increase in cardiovascular fitness according to the myocardial infarction mobilization plan based on the Heidelberger model (20) and the education about the rules of conduct in everyday life with the help of a myocardial infarction flyer (Table 1).

Table 1: The myocardial infarction mobilization plan.

*Day 1 is PCI day

The German version of the MacNew (MacNew Heart Disease Quality of Life Questionnaire, see supplementary materials) and the HADS-D (Hospital Anxiety and Depression Scale, see supplementary materials) were used to examine the quality of life, anxiety, and depression scores. The necessary permission for using the questionnaires was granted via license fees. The retrospective questionnaires were filled out independently on the first day of treatment and the day of discharge. The first time, the patients had to think about the week preceding coronary angiography and, on the day of discharge, about the week of hospitalization after PCI. They filled out the questionnaires accordingly (Table 2).

Table 2: Study protocol.

Vital parameter (blood pressure, pulse, respiratory rate and oxygen saturation)

The criteria of success for this study were: recruitment rates, data collection time, potential human optimization problems and acceptability of the program.

Procedure

Physicians at the intensive care unit, intermediate care unit, or cardiology section in Kreiskliniken Reutlingen identified potential participants based on the inclusion criteria and issued prescriptions for in-hospital physiotherapy treatment. A research assistant (physiotherapist working on the above-mentioned sections) conducted the therapy based on the mobilization plan.

Statistical analysis

We use descriptive statistics to present the sample characteristics, including means, standard deviations (SD), and percentages.

Results

Feasibility of the study methods and program:

Seventy-seven persons with acute MI were asked to join the study, and seventy-two initially consented. Five patients (6.5%) declined the participation. There were 50/72 (69.4%) persons who also completed the study. Four (5.6%) patients had to withdraw from the study because an urgent coronary bypass surgery had to be performed. One (1.4%) patient stopped because of the language barrier. Seventeen (23.6%) patients engaged in physiotherapy, but they did not hand in the second questionnaire package for different reasons on the day of discharge.

The data collection by the 50 MI patients was successful. The participants completed their questionnaire (MacNew and HADS-D) to an extent (21,22) that we could use the data, and no one had to be excluded. Physiotherapists documented all vital parameters measured according to the protocol.

Table 3 presents the demographic characteristics of the study participants. The mean age of the patients was 58.4 (SD, 11.3), ranging between 30 and 81 years. More than half of the patients were male (66%), with a diagnosis of NSTEMI (56%), with reduced left ventricular pumping function (52%) and 38% with two vessel coronary heart disease (CHD).

Table 3: Demographic characteristics of the study participants (N=50).

Concerning time management, the study was planned for six months but was extended to 9 months to reach the preliminarily defined sample size (n=50). MI patients spent an average of 6.9 (Standard deviation, SD 1.9) days in the hospital and received an average of 3.6 therapy units (SD 1.1). A therapy unit lasted between 30 minutes and 1 hour, depending on the MI mobilization stages and the interest of the patients.

Regarding the beginning of physiotherapy treatment, 36/50 (72%) patients have already been encountered in stage 1, and 14/50 (28%) persons in stage II, respectively.

The feedback from participants to the question “How satisfied were you with the physiotherapy treatment?” with answer options from 0-10, a lower score indicating higher satisfaction, showed an average of 1.6 (SD 1.0).

Discussion

The feasibility of the study methods (A) was confirmed with the recruitment, retention rates, and accuracy of data collection. The feasibility of the program (B) was confirmed with the participant’s acceptability.

The practical part of the program emphasized the importance of team communication and collaboration. The feedback from physiotherapists, physicians, and participants in the study context was essential in identifying possible changes to the program to ensure its successful implementation. However, the proposed changes were at the execution level (e.g. simultaneously with confirming an acute MI diagnosis, physicians should prescribe physiotherapy for eligible patients, preventing delays at the beginning of the physical therapy. Furthermore, at the weekend, it must be ensured that the clinical staff is well informed about the study, and remind the patients in case of discharge on the weekend to submit the completed questionnaires before they leave the hospital). We did not have to modify the design of the program.

The study methods were feasible and effective in reaching our target number of patients. From the 77 eligible patients asked, 50 persons completed the study by the recruitment. This 65% rate is similar to other results in the literature (23). Further, the low rates of missing items by the questionnaire data acquisition (within the permitted normal range (21,22), so that no questionnaire was discarded) confirm that efficient data collection is also feasible.

The extension of the study length from 6 to 9 months for a sample size of 50 patients was related partly to the coronavirus pandemic 2021/2022 and its numerous restrictions and the constantly changing regulations for patients and staff in the hospital.

Another factor that influenced the time management is that patients are also admitted on the weekend. This meant, in our case, that 28% of MI patients became physiotherapy from the second stage of the mobilization plan, depending on the admission time. This issue could only be solved with physiotherapy sessions carried out on weekends. However, this is currently not possible due to financial reasons and missing human resources.

Finally, the evidence of the acceptability of the program was provided by the high level of satisfaction regarding physical therapy. Personal feedback from the patient transmitted from physiotherapists and physicians supports these findings.

Considering the outcomes of this study, we set up the target randomized control study, mentioned in the introduction, with confidence.

Conclusion

The study method based on the investigation of physiotherapeutic treatment effects in the acute myocardial infarction (MI) phase is feasible and acceptable to MI patients.

A possibly longer recruitment period must be considered depending on the planned case number.

Declarations

Data Availability Statement: The data generated and analyzed in this study are available from the corresponding author upon reasonable request.

Conflict of Interest Statement: The authors declare that they have no conflict of interest.

Funding Statement: This study was funded by the Kreiskliniken Reutlingen GmbH, Germany.

Acknowledgement: The authors would like to acknowledge Nadja Chalamanova for supporting this study as department head, Karin Ulbrich, for her help in collecting the data and Dr. Marina Pumptow for coaching the statistical calculations.

Institutional Review Board Statement: The study was conducted according to the guidelines of the Declaration of Helsinki, and Ethical Approvals were obtained from the Ethics Committee of the Hospital Kreiskliniken Reutlingen GmbH, Germany, prior to recruitment.

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.

Author Contribution Statement: Conception of the work: KB. Collection of data: KB, KU. Analysis and interpretation of the data KB. Draft manuscript: KB. Revision of the manuscript: KH. All authors have read and approved the final version of the manuscript. All authors declare that they are responsible for all aspects of the work and they will ensure that issues relating to the accuracy of any part of the work are adequately investigated and resolved.

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