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The effect of recreational therapy application on fatigue in hemodialysis patients: a randomized clinical trial

BMC Nephrology volume 25, Article number: 368 (2024) Cite this article

Abstract

Background

Chronic Kidney Disease (CKD) is a progressive disorder that often leads to End-Stage Renal Disease (ESRD), necessitating hemodialysis (HD) treatment. Fatigue is a prevalent and debilitating symptom among HD patients, significantly affecting their quality of life. Recreational Therapy (RT) is a therapeutic recreational service designed to maintain and restore a person’s level of performance and independence in daily activities. This study aimed to evaluate the effect of a smartphone-based recreational therapy intervention on fatigue in hemodialysis patients.

Methods

This randomized controlled trial was conducted on HD patients at a hospital in Mashhad, Iran. The intervention group received a custom-designed recreational therapy mobile application, including music, comedy, exercise, and educational content. The control group received standard care. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) before and after the 30-day intervention.

Results

A total of 72 patients (36 per group) participated in the study. The intervention group demonstrated a significant reduction in overall fatigue scores and improvements across various fatigue dimensions, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation, compared to the control group (p < 0.001).

Conclusion

The smartphone-based recreational therapy intervention effectively reduced fatigue in hemodialysis patients. This approach could be a valuable complementary strategy for managing fatigue in this population. Further research is needed to explore the long-term sustainability of these benefits and the intervention’s impact on other patient-reported outcomes.

Trial registration

This study was registered in the Iranian Registry of Clinical Trials (no. IRCT20220803055608N1) on 29/08/2022.

Peer Review reports

Introduction

Chronic Kidney Disease (CKD) is a progressive and irreversible disorder in which the kidneys lose their ability to eliminate metabolic wastes and maintain fluid and electrolyte balance, leading to uremia [1]. Over 800 million people globally suffer from CKD, affecting more than 10% of the general population [2]. The prevalence of CKD has been steadily increasing; from 1990 to 2017, the global prevalence rose by approximately 41.5% [3]. By 2030, it is predicted that over 70% of patients with End-Stage Renal Disease (ESRD) will be in developing countries [4]. In Iran, the prevalence of CKD is reported to be 11.6%, with an annual increase of about 15% [5, 6]. More than 90% of CKD patients require hemodialysis (HD) [7]. Despite recent advancements in ESRD treatment, the health-related quality of life in these patients remains lower than that of healthy individuals. The complications associated with HD cause significant changes in their lives [8].

Fatigue is one of the most common and early complications in dialysis patients, affecting 60 to 97% of HD patients [9]. It is characterized by periods of physical or mental activity that reduce a person’s efficiency and effectiveness by depleting energy and motivation [10]. The chronic and debilitating nature of fatigue reduces the quality of life for patients, leading to decreased well-being, decreased ability to perform daily activities independently, social isolation, and a reduction in physical and mental energy. Fatigue also increases healthcare needs and mortality rates [11]. Additionally, it impairs cognitive functions, focus, and awareness of surroundings [12]. Previous studies have shown a relationship between high levels of perceived fatigue and depression [13, 14].

Complementary and alternative therapies, such as recreational therapy (RT), have gained attention due to the limitations and complications of drug therapy in effectively treating fatigue [15,16,17,18,19]. RT is a therapeutic service designed to maintain and restore a person’s level of performance and independence in daily activities. RT may be effective in reducing fatigue in HD patients and subsequently alleviating depression [13, 14, 20]. Given the challenges of attending group therapy sessions and the increased risk of infections for HD patients, especially during the current COVID-19 pandemic, the use of a mobile application for RT is recommended. Smartphone-based health management approaches have gained acceptance among patients with chronic diseases [21, 22]. This method falls under the broader category of telehealth, where healthcare services are delivered through digital and telecommunication technologies. The teaching planners are recommended to use this method to train nursing staff 44. Morover. RT Aplication, is a systematic process that utilizes recreation and other activity-based smartphone interventions to address the assessed needs of individuals with illnesses and/or disabling conditions, as a means to psychological and physical health, recovery and well-being. The teaching planners are recommended to use this method to train nursing staff.App localization refers to the process of adapting the app to different languages, cultures, and markets, beyond translating an app page and interface. App localization is a tactic that ensures users have a smooth journey to an in-app conversion in a targeted market. In this study, a localized application tailored to the cultural and local conditions of patients and their caregivers was designed to evaluate the effect of RT through smartphones on fatigue in patients undergoing hemodialysis treatment.

Methods

Trial design

This randomized controlled clinical trial was conducted on hemodialysis patients referred to Montaserieh Hospital in Mashhad, Iran. The clinical trial protocol follows the CONSORT flowchart (Fig. 1).

Fig. 1
figure 1

The CONSORT flowchart of study

Full size image

Participants

Study samples were selected from among hemodialysis patients referred to Montaserieh Hospital in Mashhad in 2023. Qualified patients included individuals aged 18 to 60 years, with full consciousness, owning a mobile phone with the Android operating system, having a history of at least 2 months of hemodialysis, undergoing hemodialysis two to three times a week, providing written informed consent, and having no history of anti-depression drug use or psychiatric disorders based on the patient’s statement.

Exclusion criteria

Exclusion criteria consisted of unwillingness to participate, the presence of physical or mental disorders requiring treatment or hospitalization.

Withdrawal criteria

Participant’s death, travel during the research, or failure to adhere to designated programs for at least 10 days.

Designing intervention of the recreational therapy (RT) application

Application development

RT, also known as therapeutic recreation, is a systematic process that utilizes recreation and other activity-based interventions to address the assessed needs of individuals with illnesses and/or disabling conditions, as a means to psychological and physical health, recovery and well-being.The therapeutic recreation application was developed by studying and analyzing the needs of hemodialysis patients, considering their physical and mental conditions. Content was gathered from various sources, including websites, articles, pamphlets, and educational booklets related to hemodialysis treatment. The content was reviewed by supervisors and advisors to ensure ethical considerations and research validity, with feedback incorporated. The smartphone application was developed in consultation with an informatics engineer, adhering to standard procedures and undergoing functionality verification.

Application content

App Content means text, graphics, images, audio, video, and information as well as any other material that are posted, uploaded, generated, provided or otherwise made available via the Services.The RT application content of this study included programs such as music listening, comedy movie viewing, exercise routines, and educational question-and-answer games. Patients engaged with these programs at their convenience for an average of 30 min daily. New content was provided daily, including local music segments, comedy film clips, stretching exercises, and interactive question sessions related to diet and disease education. Patients interacted with the application through animations and answered questions to enhance engagement. The application was tailored to individual preferences, allowing patients to choose from various music genres and content types, ensuring relevance to diverse age ranges and personal tastes.

Implementation of the RT application

The content of the RT application was curated by the research team and reviewed for content validity through expert judgment. Supervisors and advisors approved the materials. A panel of experts in nursing and digital health evaluated the relevance, clarity, and appropriateness of the educational and recreational components. Following ethical considerations, the localized application was developed in a standard manner.

Intervention group

The application was installed on the intervention group’s mobile phones, and patients were trained on its usage. The intervention lasted for 8 weeks, during which patients engaged with the application for 30 min each day. The researcher monitored daily program adherence through phone calls and in-person interactions, ensuring implementation according to the checklist and study protocol.

Control group

The control group participants did not undergo any scheduled RT training or app usage. However, they continued to receive standard care, which included routine hemodialysis treatments and any associated medical or educational support as per usual clinical practice.

Outcomes

Demographic data were collected during enrollment through in-person interviews at the hospital. The demographic information form included questions regarding gender, marital status, duration of hemodialysis treatment, education, income level, and place of residence. Income level was self-reported by participants as “less than enough,” “enough,” or “more than enough,” based on their subjective assessment. These categories were not determined using a validated questionnaire. The demographic questionnaire was designed based on previous studies, consultations with supervisors, and expert experience. It was completed prior to the intervention.

The MFI-20 questionnaire was administered at two time points: at the beginning of the study during enrollment and again at the end of the study after the intervention. Data were collected through in-person follow-up visits. The MFI-20 evaluates five dimensions of fatigue: general fatigue, physical fatigue, decreased activity, decreased motivation, and mental fatigue. General fatigue refers to overall daily functions, physical fatigue relates to sensations of tiredness, mental fatigue reduces cognitive abilities, decreased activity refers to a reduction in daily tasks, and decreased motivation indicates a lack of energy to initiate activities [23].

This questionnaire consists of 20 items scored on a 5-point Likert scale (ranging from 1 = “yes, completely true” to 5 = “no, completely false”). The total fatigue score ranges between 20 and 100, with higher scores indicating more fatigue. Each dimension is assessed by four questions, utilizing both positive and negative orientations to minimize respondent bias [24, 25]. The MFI-20 has been validated in Iran with a reliability coefficient of r = 0.91 and an internal consistency of α = 0.93 [24]. Its validity and reliability have been confirmed in previous studies [25,26,27].

To ensure validity, the questionnaire was reviewed by 10 faculty members from the Mashhad School of Nursing and Midwifery, and the final version was used after incorporating their feedback. Reliability was tested using Cronbach’s alpha, with a coefficient of 0.90 obtained from a sample of 20 participants meeting the study’s inclusion criteria.

Sample size and randomization

The sample size was calculated using the difference between two independent means, considering a type I error (α) of 0.05, effect size (d) of 0.90, and a power of 80%, as per Karbalaei et al. [28] This resulted in a sample size of 34 per group. Ultimately, 36 patients were assigned to each group, accounting for a 6% attrition rate.

The research sample was selected using a convenience sampling method from eligible patients referred to the hemodialysis department at Montaserieh Hospital. Participants were randomly assigned to either the intervention or control group using the website www.randomization.com. The random sequence was generated before the study commenced and kept in a sealed envelope. Once a participant met the eligibility criteria, the envelope was opened, and they were placed in one of the two groups according to the random sequence.

While participant blinding was not feasible in this trial, the outcome assessors and statisticians were blinded to the intervention type. Coding for participants and their group assignments was done by a separate individual not involved in data analysis or outcome assessment. This process ensured that the outcome assessors and statisticians collected and analyzed the data without knowledge of group assignments, preserving the impartiality of both the assessment and analysis.

Statistical methods

Data were analyzed using SPSS software version 22. Descriptive statistics summarized the demographic characteristics and fatigue scores. Independent samples t-tests were used to compare mean fatigue scores between the intervention and control groups at baseline and post-intervention. Paired samples t-tests were used to compare pre-test and post-test scores within each group. The analysis was conducted on a per-protocol basis, and an intention-to-treat analysis was performed to strengthen the evidence and explore differences in the results. A p-value of less than 0.05 was considered statistically significant.

Results

At the beginning of the study, 88 participants were assessed for eligibility. Ten individuals were excluded: nine due to not meeting the inclusion criteria and one who declined to participate. A total of 78 participants were randomized equally into two groups: intervention (n = 39) and control (n = 39). All participants in both groups received the allocated interventions. During the follow-up, three participants from each group were lost to follow-up and discontinued the intervention. At the analysis stage, 36 participants from each group were included, with no further exclusions.

In the intervention group, 52.8% (19 patients) were male, while in the control group, 58.3% (21 patients) were male, with no significant difference between the two groups (p > 0.05). The average age of the participants was 41.5 ± 13.9 years in the intervention group and 46.6 ± 11.2 years in the control group, again showing no significant difference (p > 0.05).

The average duration of hemodialysis treatment was 53.2 ± 55.5 months in the intervention group and 54.5 ± 45.3 months in the control group (p = 0.91). Except for education, the two groups were homogeneous and did not differ significantly in terms of individual indicators (Table 1).

Table 1 Demographic characteristics of the participants
Full size table

Before the intervention, there was no significant difference in the average fatigue scores between the intervention and control groups (p = 0.196). However, after the intervention, the average fatigue score was 42.3 ± 16.8 in the intervention group and 62.5 ± 13.2 in the control group, showing a statistically significant difference (p < 0.001). Intra-group comparisons also showed a significant decrease in the average fatigue score after the intervention in the intervention group (p < 0.001), while the control group experienced a significant increase (p = 0.029) (Table 2; Fig. 2).

Table 2 Mean and standard deviation of fatigue score in two study groups
Full size table
Fig. 2
figure 2

Fatigue score in two study groups

Full size image

Before the intervention, there was no significant difference in the average scores of all fatigue dimensions (general fatigue, physical fatigue, mental fatigue, decreased activity, and decreased motivation) between the two groups (p > 0.05). However, after the intervention, the average scores of these fatigue dimensions in the intervention group were: 9.3 ± 4.1 for general fatigue, 9.7 ± 4.0 for physical fatigue, 8.0 ± 4.3 for mental fatigue, 9.9 ± 4.0 for decreased activity, and 7.3 ± 3.1 for decreased motivation. These scores were all significantly lower than those in the control group (p < 0.05). Intra-group comparisons showed that the average scores of all fatigue dimensions significantly decreased in the intervention group after the intervention (p < 0.05), while in the control group, the dimensions of general fatigue and decreased activity significantly increased (p < 0.05) (Table 3).

Table 3 Mean and standard deviation of fatigue dimensions score in two study groups
Full size table

Discussion

In this study, which was conducted to investigate the effect of therapeutic recreation applications (music, video clips, games, and sports exercises, along with educational content about the disease) on the fatigue of hemodialysis patients, it was shown that after the intervention, the average fatigue score in the intervention group significantly decreased from 53.6 ± 14.1 to 42.3 ± 16.8 (p < 0.001), while this rate in the control group increased significantly from 57.4 ± 11.9 to 62.5 ± 13.2 (p < 0.05). This reduction in the intervention group was significantly observed in all aspects of fatigue, including general fatigue, physical fatigue, mental fatigue, decreased activity, and decreased motivation (p < 0.05). The results of this study are consistent with the results of Alishahi  &Sharifi et al.‘s study [2043], They also found laughter therapy effective in reducing mild depression and fatigue in hemodialysis patients. Also, in the study of Nazemian et al. [29], a positive and significant linear relationship was observed between emotional coping style and physical stressors (p < 0.001). Eroglu et al. [30] also found the Benson relaxation technique combined with music therapy to be an effective approach for managing hemodialysis-related fatigue symptoms.

Other factors that cause fatigue in hemodialysis patients are insomnia and having no physical activity [31, 32]. Insomnia causes daytime sleepiness and lack of energy, which is considered an important factor for fatigue [33]. It can be assumed that lack of energy leads to low physical well-being social isolation and increased depressive disorders in dialysis patients [34]. Maniam et al. [31] howed that 15 min of stretching before hemodialysis three times a week for 12 weeks can reduce fatigue and improve sleep disturbances in patients. According to the results of Soliman et al. [35], a significant reduction in fatigue levels, as well as in electrolytes such as serum phosphate, potassium, calcium, urea, and creatinine, was observed in ESRD patients undergoing hemodialysis after an 8-week intradialysis range of motion exercise program. Also, fatigue and musculoskeletal problems improved with yoga [36]. In addition, aerobic exercise [37], a 6-month core walking program, and exercise rehabilitation using small bicycles [38] are effective in preventing further fatigue after dialysis, increasing physical capacity and improving health-related quality of life in hemodialysis patients.

In general, patients with CKD experience high levels of fatigue regardless of age, gender, health status, and duration of hemodialysis [3943].

Fatigue reduces the quality of life of hemodialysis patients, and if not treated, it can lead to increased dependence on others, weakness, decreased physical and mental energy, social isolation, lack of follow-up treatment, loss of normal function, and increased risk of falling and falling. Eating, balance disorder, decreased alertness, decreased concentration, increased forgetfulness, increased irritability, and decreased feeling of well-being in the patient [40, 41]. Along with frequent and hard arterial punctures, fatigue was recognized as one of the most important factors of physical stress in the elderly treated with hemodialysis, and the longer the period of dialysis treatment, the more fatigue increases [42].

The study has several key strengths. First, it employed a randomized controlled trial design, which is considered a robust approach for evaluating the effectiveness of an intervention. Additionally, the researchers utilized the MFI-20 to provide a comprehensive assessment of different dimensions of fatigue, including general, physical, mental, decreased activity, and decreased motivation. The researchers also ensured the validity and reliability of the MFI-20 questionnaire for the study population. Furthermore, the use of a custom-designed smartphone application for delivering the recreational therapy intervention is a novel approach that can improve accessibility and engagement for hemodialysis patients. Finally, the study provided a detailed description of the content and delivery of the recreational therapy application, which enhances the reproducibility of the intervention.

The study also has several limitations that should be considered. One key limitation is the lack of long-term follow-up, as the study only assessed the immediate effects of the intervention and did not evaluate the sustainability of the improvements in fatigue over a longer period. Additionally, the use of a convenient sampling method may have introduced some selection bias, as the study participants may not be fully representative of the entire hemodialysis patient population. This potential selection bias should be taken into account when interpreting the study’s findings.

Conclusion

The study found that the intervention group experienced a significant decrease in overall fatigue scores and improvements across various dimensions of fatigue, including general, physical, mental, decreased activity, and decreased motivation, compared to the control group. These findings suggest that the incorporation of recreational therapy, delivered through a custom-designed mobile application, can be a valuable complementary approach to managing fatigue in hemodialysis patients. Overall, this study provides evidence that recreational therapy delivered through a mobile application can be an effective strategy to alleviate fatigue in hemodialysis patients. Further research is warranted to explore the long-term sustainability of these benefits and to investigate the potential impact of the intervention on other important outcomes, such as quality of life and depression, in this patient population.

Data availability

The datasets generated in the current study are available from the corresponding author upon reasonable request.

Abbreviations

RT:

Recreational Therapy

HD:

Hemodialysis

CKD:

Chronic Kidney Disease

ESRD:

End-Stage Renal Disease

MFI-20:

Multidimensional Fatigue Inventory

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Acknowledgements

We are grateful to the research vice-chancellor of Mashhad University of Medical Sciences for the financial support of this project.

Funding

Mashhad University of Medical Sciences.

Author information

Authors and Affiliations

  1. Master of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran

    Moein Alishahi

  2. Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

    Seyed Reza Mazloum & Samira Mohajer

  3. Department of Nursing Science, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia

    Samira Mohajer

  4. Department of Nursing, School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran

    Mohammad Namazinia

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  1. Moein Alishahi
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  4. Mohammad Namazinia
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Contributions

All authors have read and approved the manuscript. Study design: MA, SM, SRM; data collection and analysis: MA; manuscript preparation: MN, SM, SRM, MA.

Corresponding authors

Correspondence to Seyed Reza Mazloum or Mohammad Namazinia.

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Ethics approval and consent to participate

This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.NURSE.REC.1401.021) and complied with the Declaration of Helsinki. Informed consent was obtained from all participants. The study’s purpose and significance were explained to the participants who met the inclusion criteria, and they signed a written informed consent form. Participants were informed that they could withdraw from the study at any time without affecting their treatment plan, should they wish to do so. All methods were carried out in accordance with relevant guidelines and regulations aligned with the Declaration of Helsinki.

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The authors declare no competing interests.

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Alishahi, M., Mazloum, S.R., Mohajer, S. et al. The effect of recreational therapy application on fatigue in hemodialysis patients: a randomized clinical trial. BMC Nephrol 25, 368 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12882-024-03807-4

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12882-024-03807-4

Keywords

BMC Nephrology

ISSN: 1471-2369

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