Task

Research Proposal – Strength Training (Shoulder Strength) Effectiveness In Parkinson's disease patients

Project Lay Summary

Introduction

Parkinson’s disease is a neurodegenerative disorder, that affects the functional mobility of patients. Therefore, exercising is one of the best non-functional interventions to manage the above-stated PD symptoms. The current research study has focused on shoulder strength training programs to neutralize the physical challenges suffered by PD-affected patients. 

Study Aim Or Research Question

The aim of this study will be to investigate the effectiveness of different strength training types on patients affected by Parkinson’s disease. The research question has been given in the later sections of the research proposal. 

Objectives

The objectives of the research study are -
1. To expose a group of Parkinson’s disease patients to Strength training (shoulder strength).
2. To record the mobility and life quality improvement after exposing the subjects to Strength training (shoulder strength). 

Methods

A quantitative research study design will be followed for the current study. The participant group will be divided into two groups – The test (shoulder strength training exposed) and the Control (no exercise) group. Data will be collected by using both standardized and non-standardized (self-developed) questionnaires. Statistical analysis by SPSS 26.0 software was used to measure the association between shoulder strength training exercises and the reduction of PD symptoms.

Potential study outcomes and impact

A strong association is expected to exist between strength training and improvement of mobility among PD patients including their life qualities. The resources will imply that mobility-associated PD patient problems can be solved by strength training. The study has a major impact on public health since it discusses the effectiveness of a non-pharmacological intervention on PD symptoms.

However, the study outcomes will talk of specific improvement of physical challenges, with less focus on the psychological effects of PD. Therefore, depending on the potential study outcomes and impacts, future research studies should be designed accordingly. 

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Background of Study

Parkinson's disease is a specific and progressive disorder that mainly affects the nervous system and its associated body parts. Symptoms are not visible all the time. However, it has been observed that Tremors are common. However, the disorder cannot always have slowing of movement and stiffness. Therefore, there is a requirement for strength training in order to increase mobility in the patients.

The prevalence of this disease has been observed to be high in most of the nations. For example, the statistical reports say that more than 90,000 people are observed to be affected by PD per year in the US. The PD incidence increases as people age. This means that adults have higher chances of PD incidence and symptom prevalence than young ones (Ni et al. 2016). The worldwide prevalence of PD has been observed to have doubled from the previous values over the past 25 years (Srp et al. 2021).

According to the global prevalence, it has been observed that 8.5 million people are still living with PD (Oguz et al. 2022). Therefore, it can be said that the overall prevalence of PD is high in today’s time. The symptoms of this disease have been mostly observed when people are nearing 50 years of age. The prevalence of advanced Parkinson’s disease (APD) is 38% (Paul et al. 2014). This means that PD is a disease of which every type has a high prevalence (Kanegusuku et al. 2021). 

There are various pharmacological treatment methods for PD. However, these methods have a lot of side effects. Out of all the pharmacological treatments, Levodopa is the most effective PD medicine. The drug involves a natural chemical that passes into the brain and is specifically converted to Dopamine.

Levodopa is specifically combined with Lodosyn or carbidopa which protects levodopa from early conversion to dopamine, present outside the brain. This process prevents the effects of PD associated with nausea and anxiety. However, there are several side effects considering harmful effects on the liver and fatigue (Ferreira et al. 2018).

Therefore, non-pharmacological interventions (NPIs) can be stated to be beneficial for the management of PD in patients. One of the best NPIs for PD management is exercising. Strength-based exercises have been observed to be highly beneficial for PD patients. There are several benefits of strength-based training on PD-affected patients. The same has been reviewed in the following paragraphs. 

Muscle training has been shown to specifically reduce every PD symptom which is mainly neurodegenerative in nature. In other words, it can be said that regular exercising including muscle training and flexibility-increasing strategies has been observed to be beneficial in improving the condition of PD-affected patients (Shariati et al. 2023). On the other hand, dopamine-producing neuron degeneration has been observed to be a major hallmark of the disease. This function leads to improper communication between the nerve cells which results in motor symptoms including rigidity, tremors, and bradykinesia. 

Muscle training has been observed to be promising in addressing some of the physical challenges with PD. However, psychological problems are also reduced as soon as the physical challenges are neutralized. After engaging in muscle training exercises, neuroplasticity is ensured. The same has been observed to affect the brain's adaptability to adapt as well as recognize itself. This specific adaptability has been observed to promote the formation of alternate neural pathways, which further compensate for the overall loss of dopamine-producing cells. 

Training in terms of strength also improves gait among PD patients (Schlenstedt et al. 2015). A research study has shown that PD patients exposed to EMST or respiratory muscle strength training for four weeks had specific improvements in their swallowing process (Oguz et al. 2022). This means that less penetration or aspiration was observed in these patients when they were compared to patients using a placebo device. Therefore, it can be stated that EMST can improve cough function, which is problematic in PD-affected patients.

Another research study has suggested that EMST is helpful in improving the swallowing function of patients (Alves et al. 2019). Therefore, it can be said that strength training improves the internal functioning of patients including mobility. Furthermore, Clael and Bezarra (2019) have reported that strength and physical functions are improved in people suffering from PD.  The study has provided pieces of evidence that strength training improves and lowers the risk of non-fatal disease and chronic disorders.

Using the interventions for 6 weeks was helpful in reducing the functional problems by increasing flexibility, aerobic resistance, and balance in patients when compared to control groups. Helgerud et al. (2020) have talked about the importance of maximum strength training in patients affected by PD.

The results have reported that a huge impact of strength training is observed on the efferent neural channel, force generation capacity, and finally functional performance. Several improvements in functions such as stair climbing and walking were observed after using the strength training programs. However, these improvements were never observed in any of the control groups. Therefore, the positive effect of MST or muscle strength training on PD can be stated to be evidence.

This is because of the fact that functional performance increases the intensity of strength training and therefore a double positive effect is observed in PD patients, as they can do more training and get more benefits in terms of mobility and functioning (Li et al. 2012). Chung et al. (2016) have again supported the above findings from different authors. This strength training has been observed to improve muscle strength and physical functioning in people.

The review demonstrated that moderate integrity in progressive resistance training 2-3 times per week for 10 weeks can result in increasing strength, balance as well and motor functions.  However, this functional benefit is observed in people with early to moderate PD. According to Ramazzina et al. (2017), strength training plays a major role in Parkinson's disease. However, it has not been researched much in previous times. Parkinson's disease (PD) requires strength training starting from body weight and proceeding to improve motor and nonmotor symptoms in patients (Radder et al. 2020).

If strength training is well tolerated by the body, then it will be beneficial for the patients in improving both quality of life and physical parameters. However, different research conducted by Cherup et al. (2019) has talked of the comparison between power and strength training to improve muscle strength, balance, and power in individuals diagnosed with PD. This topic was not researched in either of the other research pieces of evidence shown in the previous section. Muscle strength training of the chest, leg, and hands were observed to be helpful in increasing strength and mobility among PD patients. The exercises include leg press, chest press, and bicep curls (Schlenstedt et al. 2015).

However, strength training was more beneficial than power training in improving functional mobility among PD-affected patients. Strength training has been observed to improve respiratory muscle strength and quality of life in elderly people affected by PD. Thus, another piece of evidence of the internal functions of PD-affected patients was observed in the research work of Alves et al. (2019). Peak respiratory flow was increased since exercise was effective in reducing muscle weakness and increasing flexion as well as relaxation.

However, this respiratory strength training program had a significantly longer time needed to show its effects – 16 weeks. This time length was longer than the 8-10 weeks exercise training periods observed in the other previous research works. However, previous research from 2018 has also shown the importance of resistance training on PD symptoms and QoL in elderly patients (Ferreira et al. 2018).

Before this research, only one study has been observed to talk about the effect of strength training on PD patients. Ferreira et al. (2018) have shown that resistance training had positive impacts in reducing anxiety symptoms as well as QoL in elderly people affected by PD. This Randomized Controlled Trial or RCT has proved that 24 weeks of resistance training was effective in reducing anxiety due to PD and improved the QoL. Therefore, it can be stated that there are higher reduction of pain and strength among patients. 

After going through all the above-reviewed evidence pieces, it has been observed that there is a major literature gap in the effectiveness of shoulder-based strength training on PD patients. This part of the body has still not been researched properly in previous works. Therefore, it can be selected as the main purpose of conducting the current research study. In other words, it can be said that the main reason for conducting shoulder training impacts PD patients can be stated to be the absence of enough information regarding this topic in previous research works.

Therefore, the rationale behind conducting the current research study is stated to be justified. The proposed research study will be aimed at filling the existing literature gap – the effects of shoulder strength training programs on the improvement of mobility and functioning in PD patients. 

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Purpose of study

Research question

The research question for the present research study has been developed using a PICO framework (Population Intervention Comparator Outcome).
P = PD patients
I = Shoulder strength training
C = N/A
O = Increasing shoulder strength, mobility, physical functioning, and overall gait and balance.
Research question (RQ) – “What is the effect of shoulder strength training on physical problems associated with Parkinson’s disease?”. This research question was developed based on the existing literature gap and therefore can be stated to be researched in the proposed study. 

Aim and objectives

The purpose of this study will be to investigate the effectiveness of different strength training types on patients affected by Parkinson’s Disease. This will be the aim of the current research.

The objectives of this study are –
1. To expose a group of Parkinson’s disease patients to Strength training (shoulder strength).
2. To record the mobility and life quality improvement after exposing the subjects to Strength training (shoulder strength). 

Hypotheses

Two specific research hypotheses have been developed based on the generated research question –
H0 (Null Hypothesis) – Improvement of PD symptoms based on physical challenges is not dependent on shoulder strength training. 
H1 (Alternate Hypothesis) – Improvement of PD symptoms based on physical challenges is dependent on shoulder strength training. 
Physical challenges associated with PD selected for the proposed research study include – 
Reduced strength of shoulders and shoulder pain resulting in mobility-associated disorders due to PD in patients. 

Literature review

The following keyword table was used to collect previously researched papers to review the existing body of literature in the background of this study. This section has further helped in identifying the literature gap, that will be further filled in the proposed research study. 

Table 1: Database searched and keywords table

Research Design and Methods

Research design

Research design is a significant section of every research study since it discusses the basis of the procedure used to perform the data collection and analyses. Research designs are commonly of two types – Qualitative and quantitative respectively. Both have primary and secondary sub-classes based on the data collection procedures. However, one of the above selected designs was selected for this research depending on the study topic.

Since the study topic is based on two variables – strength training and PD symptoms, a quantitative research design will be better for the research. The research design selection was hence done accordingly. Quantitative research design will be selected to carry out this research study.

The correlation between different types of strength training will be analyzed concerning their associations with physical mobility and life quality improvements of PD patients. The selected variables will be, however, not exclusively – Muscle strength test (Strength training variable) and Shoulder pain, Shoulder impingement, Subacromial impingement, and rotator cuff strength (physical mobility variables).

The main reason behind the selection of this research design is the absence of enough quantitative research studies based on shoulder strength training and its impacts on PD patients. The results will be specific in addressing the study's aim as well as objectives. 

Eligibility criteria

Eligibility criteria are significant for every primary research study. In other words, it can be stated that this criteria has been used for the selection of participants in other primary research studies too (Helgerud et al. 2020). The criteria help in differentiating the criteria of selected participants of one research from another. This criterion also brings uniqueness to the research and therefore can be stated to be a valuable section of discussion under the method chapter. 

Inclusion and Exclusion criteria

Patients affected by PD will only be included in the research study. Patients affected by other diseases will be excluded from the study. Inclusion criteria sets the features or characteristics that participants should possess, to get selected as a research participant.

On the other hand, exclusion criteria set the features or characteristics the participants should possess to be excluded from the research study. 

The inclusion criteria are –
•    Patients affected by PD.
•    Both young and old patients.
•    Shoulder strength training exposed patients
•    Patients who know English.
•    Patients between 18-75 years of age. A broad age range will be selected in order to collect different types of data that will further reduce data generalization. 

The exclusion criteria are –
•    Patients affected by other health disorders.
•    Healthy people
•    Patients subjected to other strength training methods
•    Patients below 18 years and above 75 years of age. 
•    Patients who speak and write in different languages apart from English.
These are the overall inclusion and exclusion criteria for the proposed research study.

Sampling

Random sampling will be performed to avoid selection bias from affecting the method and results of the proposed research study (Rosário et al. 2019). This sampling method has mostly been used in other quantitative research studies. The sampling process is easier and helps in sampling bias (Alves et al. 2019). A large number of patient populations will be approached from the state hospital database.

At first, these patients will be sent an invitation to participate in the research. The invitation will be sent via email. After the interests are received, a total of 100 patients will be randomly selected from them. This number has been selected since only one researcher will be conducting the whole study and lack of manpower prevents the selection of a higher number of research participants (Paul et al. 2014).

Therefore, 100 participants will be randomly selected from all the interested candidates. No specific sample size calculation was performed to avoid additional complications and lack of manpower (Clael and Bezerra 2019). A group of 100 participants will be enough to prevent selection bias and data generalization issues in the proposed study. 

Data collection tools

Muscle strength test and pain measurement will be performed and the quantitative data concerning the physical mobility variables will be recorded. Shoulder muscle strength will be measured by a 0-5 mmt grade scale followed by a pain measurement that will be performed by using VAS (Visual Analogue Scale).

Later, a 6-minute walk test will also be performed to test the overall mobility of the patients suffering from PD and exposed to shoulder strength training. The participants will be exposed to the exercise plan for 8 weeks. The idea for an exercise period was taken from another research study, where other muscle strength training with its benefits on PD patients was observed.

The amount of distance they walked will be compared to their healthy subjects to check the level of improvement after shoulder training. Therefore, one scale will be constructed by the author himself and the other scale will be the standardized VAS. For the 6-minute walk test, the standardized scale will be used (Helgerud et al. 2020).

The self-developed pain level measurement scale for shoulder strength analysis will be further subjected to statistical reliability and validity checking processes. A pilot study will be conducted with 10 participants (5 individuals in each group). These five individuals will be exposed to the procedure discussed above.

The results will be analyzed with Cronbach's alpha method in SPSS (Statistical Package for Social Sciences) software. An alpha value above 0.6 will prove that the tool is highly reliable for data collection and can be used for performing the main research with 100 participants. The other two scales are standardized, and therefore there was no requirement for reliability analyses for the other two scales (Shariati et al. 2023).

These types of data collection tools have been used in other research studies on similar research topics (Alves et al. 2019). Therefore, the selection of these data collection tools can be stated to be justified for the proposed research study. The three scale-based measurements will be done for both groups.

Measurement of pain level, shoulder strength level, and walking distance for 6 minutes will be carried out on the experiment both before exposure to shoulder muscle training exercises and after exposure to shoulder muscle training exercises. After the ratings are recorded from the scales in an Excel sheet, they will be uploaded into the SPSS software and subjected to further analyses. 

Data analysis

Correlation statistical analysis will be performed by using Microsoft Excel to identify the association between the variables and find out the effectiveness of strength training interventions in PD patients. SPSS 26.0 will be used for statistical analysis (Reyes et al. 2013). A paired sample t-test will be used for the detection of differences in shoulder strength and pain inside each of the two groups of participants.

After this analysis, the inter-group differences will be further analyzed by ANOVA to check which group had higher shoulder strengths and reduced pain. The effectiveness of these exercises will further be analyzed with respect to the 6-minute walking distance results. The correlation between shoulder strength and walking distance for 6 minutes will be analyzed to check the dependencies.

The same process will be followed for pain too. In this way, the research hypotheses agreement can be tested. The correlation analysis will tell whether PD functional mobility improvement is achieved by shoulder strength training or not. If the coefficient of correlation is observed to be below 0.5, then a weak association between the variables can be stated to exist.

On the other hand, if the coefficient of correlation is observed to be near 0.9, the strong association between variables can be stated to exist. These analysis processes have been used in other quantitative research works on this topic and therefore can be stated to be justified for the proposed research (Demonceau et al. 2017). At the end of data analysis, either the null hypothesis or the alternate hypothesis will be accepted. This result will determine whether the research aim and objectives were achieved or not. 

Ethical and Governance Considerations

Informed consent will be provided to each participant before initiating the data collection process. Ethical concerns are at the center of the proposed research study on the efficacy of shoulder strength training in individuals with Parkinson's disease (PD). The participants' rights and well-being are the primary ethical concerns. Before any data collection process is initiated, informed consent—a fundamental ethical requirement—will be taken from each participant. Participants will receive comprehensive information about the study, including its goals, methods, and potential risks.

They will be free to sign out at any time without consequences and to decide not to participate at all. Before subjecting participants to the shoulder strength training program, the researcher will carefully examine each participant's physical state in order to resolve any concerns. Individuals with Parkinson's disease might have various mobility levels, thus the exercise program will be adjusted to each individual's capacity to reduce the risk of harm. Additionally, a small-scale pilot research will be conducted to evaluate the safety and viability of the shoulder strength training program.

Data privacy and security are essential for this study. While performing the study, the personal information of participants will be treated as private, and the anonymity of the participants will be maintained. Only the researcher will have access to the identifying information, which will be securely maintained.

No third-party access to the participant information will be allowed. To protect the privacy of participants, aggregated data will be used in any published reports or outcomes. Ever specific and applicable data protection laws will be followed and ethical approval from the appropriate organization will be requested.

The research study will adhere closely to ethical guidelines and regulations, guaranteeing privacy and the safeguarding of participants' rights. Additionally, by using evidence-based therapies that improve the quality of life for PD patients, the research will preserve the beneficence concept.

Subjects will be informed of the study's possible benefits including increased mobility and better physical functioning. During the research, participants are going to be regularly monitored and informed to address any issues or discomfort they may be facing. Transparency and ethics in research will be encouraged via open channels of communication between respondents and researchers.

On a concluding note, the study design incorporates informed consent, risk evaluation, confidentiality, and data protection protocols, in addition to ethical considerations. These factors aim to put the participants' health and autonomy first while providing insightful information about the potential benefits of shoulder strength training for Parkinson's disease patients.

Participant data will be stored in the computer hard drive and secured with password protection. This data will not be subjected to any training programs concerning ethical hacking. Thus, it can be said that the research study will maintain all the ethical considerations and will further prevent the development of distrust between participants and the researcher. None of the participants are expected to opt out of the proposed study since it will be conducted by following all the ethical standards. 
 

Fig 2: Timeframe chart
Source: (Created by the Author)

 

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References

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