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

Condition(s) studied

Investigational drug(s) / intervention(s)

Self-Management and Physical Activity Education: 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 Training: 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 Training: 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 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 Syndrome.

Eligibility

Primary outcome measure(s)

• EULAR Sjogren's Syndrome Patient Reported Index-ESSPRI — 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 — 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) — 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 — 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) — 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) — 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) — 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) — 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) — 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 — 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.

Trial sites (1)

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