Primer Sjogren's SyndromeNCT07833644
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 study testing Self-Management and Physical Activity Education, Telerehabilitation-Based Single-Task Training and Telerehabilitation-Based Dual-Task Training in people with Primer Sjogren's Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primer Sjogren's Syndrome
- What is being tested?
- Self-Management and Physical Activity Education, Telerehabilitation-Based Single-Task Training and Telerehabilitation-Based Dual-Task Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Physical Therapy and Rehabilitation
Denizli, Pamukkale, 20160
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Primer Sjogren's Syndrome
- Being tested
- Self-Management and Physical Activity Education, Telerehabilitation-Based Single-Task Training, Telerehabilitation-Based Dual-Task Training
- Keywords
- Sjogren's Syndrome, cognition, Montreal Cognitive Assessment, cognitive dysfunction, Dual-task training, Telerehabilitation, Physical activity
- Medical subject headings
- Sjogren's Syndrome, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management and Physical Activity EducationOther
Before starting telerehabilitation-based single or dual-task exercise training, participants will receive comprehensive education on the immune system, the definition and symptoms of pSS, chronic pain management, relaxation and breathing exercises, joint protection, and energy conservation. Subsequently, detailed information will be provided on the types of physical activity, its effects on physical and cognitive health, barriers and facilitators, and methods to increase activity. Self-management support will be maintained throughout subsequent sessions through motivational techniques.
Telerehabilitation-Based Single-Task TrainingOther
Participants will receive synchronously online self-management and physical activity education. The program consists of core stabilization-focused functional exercises conducted online by a physical therapist 3 times a week for 8 weeks, including warm-up and cool-down periods. Attendance will be monitored, and make-up sessions will be scheduled for missed sessions. Each session will include 10 minutes of warm-up, 40 minutes of upper and lower extremity functional exercises ensuring core stabilization, and 10 minutes of flexibility cool-down. Progression will be achieved by increasing the number of repetitions and advancing exercise levels based on participant performance.
Telerehabilitation-Based Dual-Task TrainingOther
Participants will receive synchronously online self-management and physical activity education. The program consists of core stabilization-focused functional exercises conducted online by a physical therapist 3 times a week for 8 weeks, including warm-up and cool-down periods. Attendance will be monitored, and make-up sessions will be scheduled for missed sessions. Each session will include 10 minutes of warm-up, 40 minutes of upper and lower extremity functional exercises ensuring core stabilization, and 10 minutes of flexibility cool-down. The exercises will be combined with cognitive tasks. Progression will involve stating the numbers preceding or following a given number (0-100) by 1, 2, or 3; increasing place values in single-digit addition; and working memory recall (increasing from 4-digit up to 9-digit sequences).
| Study group | Role | What they receive |
|---|---|---|
| Single-Task Training Group | Active comparator | 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. Receives: Other: Self-Management and Physical Activity Education; Other: Telerehabilitation-Based Single-Task Training |
| Dual-Task Training Group | Experimental | 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. Receives: Other: Self-Management and Physical Activity Education; Other: Telerehabilitation-Based Dual-Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI
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.
Measured: Baseline and post-intervention at week 8.
Timed Up and Go (TUG) Test
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"
Measured: Baseline and post-intervention at week 8.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
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.
Measured: Baseline and post-intervention at week 8.
Sit-to-Stand Test
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.
Measured: Baseline and post-intervention at week 8.
Multidimensional Fatigue Inventory (MFI-20)
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.
Measured: Baseline and post-intervention at week 8.
Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline and post-intervention at week 8.
General Self-Efficacy Scale (GSE)
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.
Measured: Baseline and post-intervention at week 8.
36-Item Short Form Health Survey (SF-36 Health Survey)
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.
Measured: Baseline and post-intervention at week 8.
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and post-intervention at week 8.
Motivation and Social Support (Medical Outcomes Study Social Support Survey - MOS-SSS
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.
Measured: Baseline and post-intervention at week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start18 Sep 2023
- Primary completion10 Nov 2023
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primer Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following the 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). Randomization will be performed using the sealed envelope method and will continue until the required sample size, as determined by the power analysis, is achieved for both groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fzt. Aylin Keskin, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833644
- Sponsor's protocol ID
- E-60116787-020-406048
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available for sharing. The study results will be evaluated by the primary investigators and published in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07833644
- Acronym / sponsor ID
- E-60116787-020-406048
- Conditions
- Primer Sjogren's Syndrome
- Keywords
- Sjogren's Syndrome, cognition, Montreal Cognitive Assessment, cognitive dysfunction, Dual-task training, Telerehabilitation, Physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following the 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). Randomization will be performed using the sealed envelope method and will continue until the required sample size, as determined by the power analysis, is achieved for both groups.
| Arm | Type | Receives |
|---|---|---|
| Single-Task Training Group | Active comparator | Other: Self-Management and Physical Activity Education, Other: Telerehabilitation-Based Single-Task TrainingParticipants 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. |
| Dual-Task Training Group | Experimental | Other: Self-Management and Physical Activity Education, Other: Telerehabilitation-Based Dual-Task TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management and Physical Activity EducationBefore starting telerehabilitation-based single or dual-task exercise training, participants will receive comprehensive education on the immune system, the definition and symptoms of pSS, chronic pain management, relaxation and breathing exercises, joint protection, and energy conservation. Subsequently, detailed information will be provided on the types of physical activity, its effects on physical and cognitive health, barriers and facilitators, and methods to increase activity. Self-management support will be maintained throughout subsequent sessions through motivational techniques. | Other | Dual-Task Training Group, Single-Task Training Group |
| Telerehabilitation-Based Single-Task TrainingParticipants will receive synchronously online self-management and physical activity education. The program consists of core stabilization-focused functional exercises conducted online by a physical therapist 3 times a week for 8 weeks, including warm-up and cool-down periods. Attendance will be monitored, and make-up sessions will be scheduled for missed sessions. Each session will include 10 minutes of warm-up, 40 minutes of upper and lower extremity functional exercises ensuring core stabilization, and 10 minutes of flexibility cool-down. Progression will be achieved by increasing the number of repetitions and advancing exercise levels based on participant performance. | Other | Single-Task Training Group |
| Telerehabilitation-Based Dual-Task TrainingParticipants will receive synchronously online self-management and physical activity education. The program consists of core stabilization-focused functional exercises conducted online by a physical therapist 3 times a week for 8 weeks, including warm-up and cool-down periods. Attendance will be monitored, and make-up sessions will be scheduled for missed sessions. Each session will include 10 minutes of warm-up, 40 minutes of upper and lower extremity functional exercises ensuring core stabilization, and 10 minutes of flexibility cool-down. The exercises will be combined with cognitive tasks. Progression will involve stating the numbers preceding or following a given number (0-100) by 1, 2, or 3; increasing place values in single-digit addition; and working memory recall (increasing from 4-digit up to 9-digit sequences). | Other | Dual-Task Training Group |
Primary outcome
EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available for sharing. The study results will be evaluated by the primary investigators and published in academic journals.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management and Physical Activity Education, Telerehabilitation-Based Single-Task Training and Telerehabilitation-Based Dual-Task Training in people with Primer Sjogren's Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI (time frame: Baseline and post-intervention at week 8.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.