The Effect of Telerehabilitation Based Physical Activity Training Associated With Single and Dual Task Training on Physical and Cognitive Functions in Individuals With Primary Sjögren's Syndrome: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI
研究概览
简要总结
It was aimed to investigate the effectiveness of telerehabilitation-based single and dual-task training, combined with physical activity training, on symptom severity, functional status, fatigue, quality of life, cognitive level, sleep, self-efficacy, and satisfaction levels in individuals with Primary Sjögren's Syndrome.
详细描述
When the literature is reviewed, it is observed that studies on internet-based exercise applications in individuals with rheumatic diseases are limited; moreover, no such exercise method has been implemented in individuals with Primary Sjögren's Syndrome (pSS). In existing studies, individuals were encouraged to engage in physical activity through an internet-based application, and the benefits of being active were provided within the scope of patient education. Consequently, it has been reported to effectively improve physical activity levels. Simultaneously, it has been documented that this approach can enhance endurance and is both safe and feasible. Distinct from the literature, our study is the first to integrate single and dual-task training-delivered alongside physical activity training based on physical activity impairment in pSS-into an internet-based telerehabilitation method. Therefore, this study aims to investigate the effectiveness of telerehabilitation-based single and dual-task training, combined with physical activity training, on symptom severity, functional status, fatigue, quality of life, cognitive level, sleep, self-efficacy, and satisfaction levels in individuals with Primary Sjögren's Syndrome.
At least 36 individuals with Primary Sjögren's Syndrome aged 18-65, who are followed up by the Pamukkale University Rheumatology Clinic and diagnosed according to the American-European Consensus Group classification criteria, with no other diseases affecting their functions, will be included in the study (Single-Task Training Group, n=18; Dual-Task Training Group, n=18).Participants' demographic data (name, gender, years of education, etc.), clinical data (age, height, weight, chronic diseases, etc.), and their perspectives on physical activity, obtained through questions derived from a literature review, will be recorded in the demographic registration form.Symptom severity will be evaluated using the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI). The dual-task assessment will be performed as a motor-cognitive task by adding a backward counting task during the Timed Up and Go (TUG) Test. Physical activity levels will be assessed with the International Physical Activity Questionnaire Short Form (IPAQ-SF), lower extremity muscle strength with the Sit-to-Stand Test, fatigue with the Multidimensional Fatigue Inventory (MFI-20), cognitive level with the Montreal Cognitive Assessment (MoCA), self-efficacy with the General Self-Efficacy Scale, quality of life with the Short Form 36 (SF-36) Health Survey, sleep quality with the Pittsburgh Sleep Quality Index (PSQI), and motivation level with the Social Support Scale. Assessments will be administered twice by a blinded assessor: before the training begins and at the eighth week following its completion.Following the initial assessments, individuals with Primary Sjögren's Syndrome will be randomly allocated into two groups: the single-task training group (n=18) and the dual-task training group (n=18). Blinding will be ensured by keeping the trainer unaware of the assessment results, and the statistician blinded to the allocation of the groups.
Educational ApproachesSelf-Management and Physical Activity Education:Before commencing either the single-task or dual-task exercise training via telerehabilitation, participants will receive comprehensive education covering the definition of the immune system and pSS, expected symptoms and their interrelations, chronic pain and its management, relaxation and breathing exercises, joint protection principles, and energy conservation techniques. Subsequently, detailed information will be provided regarding the definition and types of physical activity, its effects on physical and cognitive health, facilitators and barriers to activity, and methods to increase physical activity. Self-management support will be maintained alongside the exercises in subsequent sessions through motivational techniques.
Telerehabilitation-Based Single-Task Training:Participants in this exercise group will receive the same self-management and physical activity education shared synchronously online. The exercise program will consist of functional exercises focusing on core stabilization, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a cool-down program consisting of 10 minutes of flexibility exercises. Progression in exercise training will be achieved by increasing the number of repetitions and advancing the exercise levels based on the participants' performance.
Telerehabilitation-Based Dual-Task Training:Participants in this exercise group will receive the same self-management and physical activity education shared synchronously online. The exercise program will consist of functional exercises focusing on core stabilization, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a cool-down program consisting of 10 minutes of flexibility exercises. The exercises provided in the single-task training will be performed by combining them with cognitive tasks. Progression in cognitive tasks will be implemented as follows: stating the number preceding a given number between 0 and 100, then advancing to 2 numbers and 3 numbers preceding; increasing the place value in the summation of single-digit numbers; recalling a given 4-digit sequence and subsequently increasing it up to 9 digits; and stating the number following a given number between 0 and 100, then advancing to 2 numbers and 3 numbers following.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with Primary Sjögren's Syndrome according to the 2016 ACR/EULAR classification criteria,
- •Having a salivary gland incisional biopsy graded as Grade 3 or 4 according to the Chisholm-Mason classification,
- •Being between 18 and 65 years of age,
- •Having no other concomitant diseases that could affect physical functions,
- •Having a stable medication regimen for at least 3 months or longer,
- •Providing voluntary consent to participate in the study,
- •Having internet access and the ability to use a smartphone.
排除标准
- •Refusal to participate in the study,Severe psychiatric conditions that prevent participation (e.g., psychotic disorders),
- •Cognitive impairment severe enough to affect cooperation,
- •Psychiatric illness severe enough to affect cooperation,
- •Being pregnant,Inability to understand or speak Turkish,
- •Using a walking aid,Diseases affecting the central nervous system (e.g., multiple sclerosis, Parkinson's disease),
- •Heart failure or lung pathology at a level that affects activities of daily living,
- •Having any musculoskeletal, orthopedic, neurological, or psychological disease that could prevent participation in exercise,
- •Having an additional concomitant rheumatic disease,
- •Having undergone surgical or arthroscopic operations within the last 1 year,
- •Presence of malignancy,
- •Smoking or alcohol consumption.
研究组 & 干预措施
Single-Task Training Group
Participants in this group will receive self-management and physical activity education shared synchronously online. The exercise program will consist of core stabilization-focused functional exercises, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Attendance will be monitored to ensure participants' full participation in all sessions, and make-up sessions will be scheduled for any missed sessions. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a 10-minute flexibility cool-down program. Progression in exercise training will be achieved by increasing the number of repetitions and advancing the exercise levels based on the participants' performance.
干预措施: Self-Management and Physical Activity Education (Other)
Single-Task Training Group
Participants in this group will receive self-management and physical activity education shared synchronously online. The exercise program will consist of core stabilization-focused functional exercises, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Attendance will be monitored to ensure participants' full participation in all sessions, and make-up sessions will be scheduled for any missed sessions. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a 10-minute flexibility cool-down program. Progression in exercise training will be achieved by increasing the number of repetitions and advancing the exercise levels based on the participants' performance.
干预措施: Telerehabilitation-Based Single-Task Training (Other)
Dual-Task Training Group
Participants in this group will receive self-management and physical activity education shared synchronously online. The exercise program will consist of core stabilization-focused functional exercises, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Attendance will be monitored to ensure participants' full participation in all sessions, and make-up sessions will be scheduled for any missed sessions. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a 10-minute flexibility cool-down program. The exercises will be performed by combining them with cognitive tasks. Progression in cognitive tasks will involve backward and forward number sequencing, increasing place values in calculations, and working memory recall tasks (increasing from 4-digit up to 9-digit.
干预措施: Self-Management and Physical Activity Education (Other)
Dual-Task Training Group
Participants in this group will receive self-management and physical activity education shared synchronously online. The exercise program will consist of core stabilization-focused functional exercises, including warm-up and cool-down periods, conducted online by a physical therapist 3 times a week for 8 weeks. Attendance will be monitored to ensure participants' full participation in all sessions, and make-up sessions will be scheduled for any missed sessions. Each exercise session will begin with 10 minutes of warm-up exercises, followed by 40 minutes of functional exercises targeting the upper and lower extremities while ensuring core stabilization, and will be completed with a 10-minute flexibility cool-down program. The exercises will be performed by combining them with cognitive tasks. Progression in cognitive tasks will involve backward and forward number sequencing, increasing place values in calculations, and working memory recall tasks (increasing from 4-digit up to 9-digit.
干预措施: Telerehabilitation-Based Dual-Task Training (Other)
结局指标
主要结局
EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI
时间窗: Baseline and post-intervention at week 8.
The scale includes three separate 0-10 Visual Analog Scales (VAS) to evaluate the levels of dryness, pain, and fatigue. The total score is calculated by dividing the sum of the scores by three. Higher scores indicate worse patient-reported symptom severity. The Turkish validity and reliability of the index were conducted to assess patient-reported symptom severity.
Timed Up and Go (TUG) Test
时间窗: Baseline and post-intervention at week 8.
In this test, for the single-task condition, participants will first be asked to rise from a chair without using their arms, walk 3 meters as quickly as possible without running, turn around, walk back to the chair, and sit down without using their arms. For the dual-task condition, a cognitive task will be added, and participants will be asked to perform the test while counting backward aloud by twos, starting from a random number greater than 100; the test result will be recorded in seconds. Each test condition will be repeated three times, and the average values will be recorded. A two-minute rest will be provided between tasks to prevent fatigue. The number of errors made by the participant during the test will also be recorded. To evaluate the performance rate under dual-task conditions, the following formula will be used:Dual-Task Performance Cost/Rate = \[(Dual-Task Time - Single-Task Time) / Single-Task Time\] × 100"
International Physical Activity Questionnaire Short Form (IPAQ-SF)
时间窗: Baseline and post-intervention at week 8.
In evaluating the International Physical Activity Questionnaire, the criterion is that each activity must be performed for at least 10 consecutive minutes. It questions the duration (in minutes) over the last 7 days of vigorous physical activity (e.g., football, carrying heavy loads, weightlifting, basketball, fast cycling), moderate physical activity (e.g., carrying light loads, cycling at a regular pace), walking, and daily sitting time. For the analysis, these values are converted into Metabolic Equivalent of Task (MET) values corresponding to the resting metabolic rate, and the total physical activity score is calculated using the formula of MET-minutes/week. The Turkish validity and reliability study of the scale was conducted.
Sit-to-Stand Test
时间窗: Baseline and post-intervention at week 8.
Participants' lower extremity muscle strength and functional performance will be evaluated using the 30-Second Sit-to-Stand Test. Before the test, the participant's feet must be in full contact with the floor, and their arms crossed over the chest. Participants are asked to stand up and sit down as quickly as possible for 30 seconds from a standard, armless chair with back support (average height of 44 cm). The number of completed full repetitions of sitting and standing is recorded. Completing fewer than 10 repetitions in 30 seconds indicates lower extremity muscle weakness.
Multidimensional Fatigue Inventory (MFI-20)
时间窗: Baseline and post-intervention at week 8.
The scale evaluates 5 dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. It contains a total of 20 items, with 4 items in each dimension. The items are scored from 1 to 5. The score for each subscale ranges from 4 to 20, with higher scores representing more severe fatigue. It has been utilized in individuals with cancer, Parkinson's disease, rheumatoid arthritis (RA), systemic lupus erythematosus, and Sjögren's syndrome.
Montreal Cognitive Assessment (MoCA)
时间窗: Baseline and post-intervention at week 8.
The Montreal Cognitive Assessment serves as a brief screening test for mild cognitive impairment to measure cognitive functions. The pen-and-paper test takes approximately 10 to 20 minutes to administer. It consists of seven subscales, which assess visuospatial and executive functions through clock-drawing, cube-copying, and trail-making test part B for five points; naming with a five-word list learning and repetition for three points; memory retrieval for five points; attention using a goal-directed clapping task for six points; language fluency for three points; abstract thinking via similarities between words for two points; and orientation regarding day, month, year, and place for six points. Total scores range from 0 to 30, with higher scores indicating better performance. Scores below 26 points indicate a risk of cognitive impairment and suggest a potential mild cognitive condition. The Turkish validity and reliability study of the test has been conducted.
General Self-Efficacy Scale (GSE)
时间窗: Baseline and post-intervention at week 8.
The scale consists of 10 items evaluated on a 4-point Likert-type scale (1: not at all true, 2: hardly true, 3: moderately true, 4: exactly true). The total score ranges from 10 to 40. The Turkish adaptation studies of the scale were conducted.
36-Item Short Form Health Survey (SF-36 Health Survey)
时间窗: Baseline and post-intervention at week 8.
The scale consists of 36 items that measure eight dimensions: physical functioning (10 items), social functioning (2 items), role limitations due to physical health (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), bodily pain (2 items), and general health perceptions (5 items). The second question of the scale evaluates the perception of health change over the past 12 months, while the remaining questions assess the past four weeks. The response options include yes/no formats for specific questions, and Likert-type rating scales for the others. Certain items are reverse-scored to calculate the final outcomes. The subscales evaluate health on a score ranging from 0 to 100, where 0 indicates poor health status and 100 indicates good health status. The Turkish validity and reliability study of the scale has been conducted.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline and post-intervention at week 8.
The PSQI is a self-report scale that evaluates sleep quality and sleep disturbances over a one-month time interval. In the scoring of the PSQI, 18 items are included in the evaluation. The PSQI consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Some of these components are determined by a single item, while others are obtained by grouping several items. Each item is rated on a score from 0 to 3, and the sum of the seven component scores yields the total PSQI score. The total score ranges from 0 to 21, with higher total scores indicating poorer sleep quality. A total PSQI score of less than or equal to 5 indicates good sleep quality, whereas a score greater than 5 indicates poor sleep quality. The Turkish validity and reliability study of the scale has been conducted.
Motivation and Social Support (Medical Outcomes Study Social Support Survey - MOS-SSS
时间窗: Baseline and post-intervention at week 8.
The first item evaluates the number of close relatives and friends (structural social support). The remaining 19 items are assessed using a 5-point Likert-type scale ranging from 1 (never) to 5 (always). The survey consists of four subscales: emotional/informational support (8 items), positive social interaction (3 items), affectionate support (4 items), and tangible support (3 items). The Turkish validity and reliability study of the scale has been conducted.
次要结局
未报告次要终点
研究者
Fzt. Aylin Keskin
MSc Physiotherapist
Pamukkale University