Effects of a self-care educational program via telerehabilitation on quality of life and caregiver burden in amyotrophic lateral sclerosis: a single-blinded randomized clinical trial protocol

Introduction The implementation of a telerehabilitation protocol for self-care in the routine of caregivers of individuals with amyotrophic lateral sclerosis (ALS) has been associated with reduced levels of stress and improved quality of life. Moreover, it may reduce the difficulty of traveling to perform physical or other self-care activities. Thus, this study designed a clinical trial protocol to investigate the effects of a self-care education program via telerehabilitation on the burden and quality of life of caregivers of individuals with ALS. Methods This single-blinded randomized clinical trial will recruit 26 caregivers and randomly allocate them to the experimental (EG = 13) or control group (CG = 13). The EG will receive an informative booklet and participate in a 6-week synchronous telerehabilitation program with a neuropsychologist, nutritionist, and physiotherapist to discuss physical and mental health. The CG will receive an informative booklet on self-care and physical activity and weekly phone calls for 6 weeks to solve questions about the booklet. Outcomes will include the caregiver burden (Zarit scale), quality of life (World Health Organization Quality of Life BREF), pain (McGill Pain Questionnaire), stress (Perceived Stress Scale), and depression (Beck Depression Inventory), which will be evaluated at the baseline after the six-week program and 30 days after the program. Additionally, we will assess daily the nocturnal awakenings, sleep patterns, level of physical activity, and heart rate variability. Discussion This study aimed to investigate the effectiveness of telerehabilitation for caregivers of individuals with ALS. If effective, this program could be disseminated among health professionals, increasing the possibility of remotely monitoring individuals with difficulty performing physical activities. Trial registration number NCT05884034 (clinicaltrials.gov).


PRESENTATION
Welcome, caregiver! This booklet was specially designed for you who participate in the RevELA project caregivers course, offered by the Laboratory for Technological Innovation in Health (LAIS) at the Federal University of Rio Grande do Norte (UFRN).
You are a fundamental person in the daily search for the quality of life of the person with Amyotrophic Lateral Sclerosis. Your dedication and commitment are very important at this time; however, everyday activities can leave you feeling tired, worn out, and impatient. Thus, we developed a self-care program to guide you through your physical and psychological well-being, as well as your routine and diet.
This project will last six weeks, and you will be closely monitored so that we can help you practice the guidelines in this booklet on physical exercises, routine, food, and emotions. Throughout this period, we will assess how this new routine may impact your quality of life.
With this booklet, we hope you will adopt a healthier lifestyle, including physical activity in your daily life, and understand the signs and symptoms your body gives when it needs care. Our goal is to have you, the caregiver, as the main star. So, let's talk about your physical, mental health, and overall well-being. Shall  You are dear.
You are loved.
Prevents and improves depressive symptoms.
You are very important, remember that!

Figure 1: Front thigh stretch.
Hold on to the wall with your left hand, and, with your right hand, pull your right leg towards your buttock. Count to 30, and repeat the procedure with your other leg.  Lying down and using a sheet, keep your right knee bent and your left knee extended as in the image, and count to 30. Then do the same procedure with the other leg.  While lying down, pull both legs towards your torso, hug them and keep both in a bent position for 30 seconds. Then return to the starting position and repeat the movement one more time.  Lying on your stomach, bend your legs while keeping your hands on the floor and stretch your spine until your buttocks touch your heels. Stay in this position for 30 seconds, return to the starting position and then repeat the movement.  Moving your body is an important aspect to your health. You can choose the activity that gives you the most pleasure, such as walking, water aerobics, weight training or dancing. This activity has to be part of your routine and needs to be performed at least 3 times a week. You can also perform exercises at home, adapting the material you already have.
We'll teach you how to do it! You will do mobility exercises to warm up your joints. For the exercises that will be presented below, repeat each movement 10 times.  With your spine straight and leaning forward, you'll do shoulder movements. First, move back and forth; repeat the movements to the sides; and finally, make circular movements with your shoulders. Don't forget to bend your legs slightly! Repeat it 10 times on both sides.  Standing with your hands on your hips, you will make hip movements to both sides and then circular movements. You should repeat both exercises 10 times. After that, rest a little and do 10 more repetitions. Don't forget to bend your legs a little!  In a sitting position, do foot exercises, first putting the toes up and down; immediately afterward, putting the toe in and out. Do each exercise 10 times on each foot. Then repeat the movements (10 times).

SHALL WE EXERCISE?
To continue taking care of your physical health, we will teach you exercises to increase the strength of some muscle groups. These exercises will improve your movements, decrease pain and keep your posture as best as possible.
Our body is an ingenious machine that needs regular care. One way of caring is muscle strengthening. Strong muscles help us maintain our posture, balance, and perform routine activities. The natural aging process causes muscle loss and joint overload, generating pain processes and increasing the risk of falls. That's why it's very important to strengthen your muscles frequently.
So let's start?

SQUAT
With this exercise, you will strengthen some large muscle groups responsible for everyday activities such as walking and standing. You will throw your hips back and do the sitting movement, repeat this movement 8 times, rest 1 min and repeat the series (of 8) for 2 more times, that is, 3 sets of 8 reps. If you can't do it that way, you can place a chair against the wall and sit/stand up 3 sets of 8, resting 1 min between each set. With this exercise, you will strengthen some of the large muscle groups responsible for everyday activities such as walking and standing. You will have to tilt your hips back, and then you will have to sit down. Repeat this movement 8 times and rest for 1 minute. Repeat the series (8 reps and 1-minute rest) 3 times.  With a chair behind you, repeat the sit and stand motion without using the armrest. Do this 8 times, rest 1 minute, and repeat the series 3 times.

USING A STICK
With this exercise, you will mobilize the joints and muscles of the shoulders and arms. The arms are responsible for fundamental everyday activities. You use them to feed yourself, and take care of the house and yourself. For these exercises, you can use a stick, broomstick, or something similar. With the stick in hand, make lifting movements, first forward, then to the sides and back. Follow the images, and do 3 sets of 10. Between sets, rest for 1 minute. This will keep your muscles active and healthy.

BRIDGE
This exercise will help you strengthen the muscle groups responsible for maintaining good posture and related activities. First, you should lie down, preferably on the floor, bend your legs, keep your arms straight at your sides, and lift your hips. Then, with your buttocks up there, you count to 5. Do 3 sets of 10 repetitions, resting 1 minute between each set.

LEG RAISE
With this exercise, you will strengthen muscle groups in your hips and legs. They are responsible for maintaining posture and everyday activities such as standing and walking.
Still lying down, bend one leg and raise the other extended leg to the height of the bent leg. Repeat the exercise 10 times and then switch legs. Do 3 sets of 10 reps, resting 1 minute between each set. Now that you have completed the first exercise, lie on your side, slightly bend the lower leg and raise the extended leg, as in the image. Do 3 sets of 8, resting 1 minute between each set.

PLANK
To finish the day's cycle of activities, do an exercise to strengthen your spine and abdominal muscles. You will continue lying on your stomach and lift your body, supporting your weight on your arms and feet, as in the image. Next, align your spine, look down and hold this position for 30 seconds. Repeat the movement 3 times, with a 1-minute rest after each repetition.

How are you feeling?
Got too tired of the exercises? If tomorrow you feel too sore, decrease the number of repetitions next time, but do not Give up!!! Remember that your goal is to have a strong, healthy body. Let's talk about your psychological well-being! It is necessary to understand that the body and the mind are strongly linked. So if your body isn't right, your head won't be either, and the opposite is also true. You've already learned how to exercise your body, so let's see some tips on how to keep your mind well.. Have you ever stopped to think about how YOU are feeling? Currently, there are many strategies to achieve well-being, but achieving the long-awaited well-being requires many emotional skills from us. This intensifies when it comes to illness.

PSYCHOLOGIC WELL-BEING
ALS is a disease that requires a lot of availability and dedication, which causes an emotional overload that can result in episodes of depression, and anxiety, in addition to sleep disturbance It is necessary to resignify negative thoughts and learn to take care of yourself too! In this sense, strengthening the bond between family members and caregivers is very important so there are no overloads.
Take time for yourself, take care of yourself, seek to love yourself, and prioritize your needs.
We all have physical and emotional limits, and we have to respect them. Do you understand that, for everything to flow in a healthy and organized way, your tasks need to fit into your routine? Everyone has a routine, but the difference is that you, the caregiver, are responsible for two -yours and the patient's. In order for everything to work well without overwhelming you, the schedules need to be well adjusted.
An important tip for organizing schedules is: make charts! The charts will help you to better visualize your routine. Organize your day and week tasks into schedules. If you have any activities beyond your reach, remember to ask for help!
The clinical evolution of ALS imposes a different rhythm at home and in the family, thus changing their routines. This change, associated with the progression of symptoms and poor distribution of tasks, presents itself as a source of stress.
Typically, a family member takes on most of the responsibilities for the patient, such as general care, doctors, therapies, finances, and household management. Thus, it is necessary for you, the caregiver, to take time for yourself, for self-care and for your needs.
Try to separate your feelings so you don't get absorbed in the tasks related to care, so that your lack of physical and mental energy doesn't cause you psychic illness. But, remember: you also need to be careful! Take a moment in the day for your needs, try to distract yourself, insert physical activity and leisure into your routine, maintain your social relationships, eat well, chase your dreams, and maintain your identity.
Schedule weekly for patient care, appointments, and therapies. In this process, remember your needs, and, with the same commitment to caring for the other, TAKE CARE of yourself too. A healthy diet is nutritionally adequate and keeps your body, mind, and social relationships balanced, preventing and treating diseases. The caregiver must take care of himself, paying attention to a tasty, balanced, and nutrient-rich diet, always valuing regional and seasonal foods, which are more accessible and easier to insert during the day.
The act of eating is part of our routine at various times of the day (breakfast, snacks, lunch, and dinner). What are the best choices to maintain health and perform well on a day-to-day basis as a caregiver? These are: • Don't skip meals, avoid fasting for long periods. Remember that you need energy to carry out everyday activities.
• Always carry a snack in your bag or backpack! For more practicality, prepare it 1 day before leaving the house and pack it well in a place suitable for the type of food and/or preparation: dairy products and meat products in the fridge or thermal bags, fruits with skin in a dry environment.
• Give priority to consuming fresh foods. These include grains, roots, tubers, vegetables, nuts, wholemeal flour, milk, eggs, and meats. • • Reduce the consumption of saturated and trans fats (fried foods) and refined sugars (white sugar and candies in jam and syrup).
• • Avoid the routine consumption of processed and ultra-processed foods. These are fruit in syrup and candied, jerky and bacon, canned goods, stuffed cookies, ice cream, candies and sweets, soda and powdered soft drinks, sausages, hydrogenated vegetable fat, food additives, etc.
• • Whenever you can, eat in quieter environments, and slowly. Pay attention to your food and, if possible, with a pleasant company.
• • Reduce salt consumption, avoid putting the salt shaker on the table. Use only when preparing meals.
• • Maintain a good water intake, between 1500-2000 ml per day. Your body needs this hydration, your intestines work better, and urine helps eliminate toxins from the body. Thus, the skin is more hydrated.
• • Look at food labels before you buy them. Avoid taking foods that contain many chemical additives that often have words that are difficult to pronounce, such as phosphoric acid, butylhydroxyanisole, ethylenediaminete calcium, and disodium tetraacetate, benzoic acid, dioctyl sodium sulfosuccinate.. Set a reminder on your phone or use apps to remind you to drink water.
If you prefer to vary, complement the hydration with natural juices and teas.
Give preference to foods rich in water, such as fruits and vegetables.
Hot drinks such as teas also help relieve cold and u symptoms. Figure 21: Tips to facilitate hydration. To end our meetings, let's talk a little about the need for you to take time to relax. You can resort to any form of relaxation: watching your favorite TV show, spending time outdoors, taking a walk in a square or on the beach, or even traveling. What matters is that you disconnect a little from the workday and stress and focus on your well-being. If you carry out all the tips in this booklet, a habit change is already happening. You will be feeling healthier both physically and mentally; you already understand your body's signals and are aware of the need for rest and relaxation.

DRINK WATER
In your routine, take a moment, even once a week, to relax. Let's teach you a quick and effective exercise for this purpose! The first step is breath control. You will do 10 repetitions of deep inhalation through the nose, releasing the air calmly through the mouth and taking the focus off the problems experienced. You can sit or lie down; however, the lying position is most recommended for deeper relaxation, as shown in the image below. Lying down, with your limbs relaxed, focus on your breathing. When your attention is completely on your breath, focus on relaxing your muscles from your feet to your head. Try to feel the weight of your head, torso, arms, and legs.  Sitting or standing, with your spine erect, make repeated movements, as if you were going to put your ear to your shoulder, from right to left, and back. Repeat 10 times for each side, always associated with deep breaths. Finally, move your head up and down, repeating the movement 10 times in each direction.   Sitting on your legs, curve your spine, stretch your arms with your hands flat on the floor. When you reach your limit, count to 30, repeat it 2 times. Remember to associate movement with breathing.