Investigating the Relationship Between the Biopsychosocial Status of Individuals Diagnosed With Scleroderma and Their Physical Performance and Functionality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 6-Minute Walk Test
研究概览
简要总结
Physical functionality and performance are important for individuals diagnosed with scleroderma. There is a need to address children and adults diagnosed with scleroderma comprehensively and to evaluate them on a biopsychosocial basis to support their disease management. In light of all this literature, the aim was to evaluate the biopsychosocial characteristics of both pediatric and adult scleroderma patients and to examine their physical performance and functionality.
Additionally, this study aims to identify effective tests that can be used in future research to assess physical performance and functionality in individuals diagnosed with scleroderma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases diagnosed with scleroderma,
- •Cases aged 7-18 years will be included.
排除标准
- •Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- •Cases that are not willing to participate in the study will be excluded.
- •Having participated in a regular exercise program for the past 3 months
- •Individuals who are not willing to participate in the study
- •*For adults diagnosed with scleroderma*
- •Inclusion Criteria:
- •Individuals diagnosed with scleroderma,
- •Individuals over the age of 18 will be included.
- •Exclusion Criteria:
- •Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- •Individuals who are not willing to participate in the study will be excluded.
- •Having participated in a regular exercise program for the past 3 months
- •Individuals who are not willing to participate in the study
结局指标
主要结局
6-Minute Walk Test
时间窗: Two weeks
Participants are asked to walk as quickly as they can along a 30-meter corridor. The total distance will be measured in meters. Fatigue, pain and dyspnea will be monitored using the Modified Borg Scale.
Timed Up and Go Test
时间窗: Two weeks
The time it takes for a person to get up from a chair with back support, walk 3 meters at a normal pace, and return to the chair is measured in seconds to evaluate lower extremity balance. The test will be performed 3 times.
10-Step Stair Climbing Test
时间窗: Two weeks
To assess the subject's lower extremity strength and dynamic balance, the time taken to quickly climb and descend a staircase with 10 steps, each measuring 16-20 cm high and equipped with a handrail, is recorded in seconds. The test is repeated three times, and the times are recorded.
10-meter walk test
时间窗: Two weeks
The individual is on a 10-meter path. The assessment is performed in three repetitions and recorded in seconds.
30-second sit-to-stand test
时间窗: Two weeks
It is performed to evaluate lower extremity endurance by having the individual stand up from a chair with their arms crossed over their chest and then sit back down. The individual is instructed to repeat this as quickly as possible for 30 seconds. The score for this assessment is the number of times the person fully stands up from a sitting position with arms crossed within 30 seconds.
Glittre Activities of Daily Living Test
时间窗: Two weeks
It consists of a cycle of standardized activities such as walking, carrying weights, climbing stairs, and moving objects on a shelf. The equipment required for the test includes a chair, steps, a shelf, a backpack, weights (0.5 kg-2.5 kg), and a stopwatch. The patient completes the 10-meter course created for the test for five laps, and the time is recorded.
次要结局
- Frailty Scale(Two weeks)
- Childhood Health Assessment Questionnaire (CHAQ)(Two weeks)
- Juvenile Arthritis Quality of Life Questionnaire (JAQQ)(Two weeks)
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Patient(Two weeks)
- Juvenile Arthritis Biopsychosocial Scale-JAB-Q-Family(Two weeks)
- Pain Catastrophizing Scale-Parent (PCS-P)(Two weeks)
- Child and Adolescent Scale of Participation (CASP)(Two weeks)
- Scleroderma Health Assessment Questionnaire (SHAQ)(Two weeks)
- Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)(Two weeks)
- Short Form-36 (SF-36)(Two weeks)
- Central Sensitization Scale (CSS)(Two weeks)
- Hospital Anxiety and Depression Scale (HADS)(Two weeks)
- Modified Rodnan skin score (MRSS)(Two weeks)
- Localized Scleroderma Assessment Tool (LoSCAT)(Two weeks)
- Modified Hand Mobility in Scleroderma Test (mHAMIS)(Two weeks)
- Pain Catastrophizing Scale-Children (PCS-C)(Two weeks)
- Clinical Frailty Scale(Two weeks)
- Transition Readiness Assessment Questionnaire (TRAQ)(Two weeks)
- Pain Catastrophizing Scale(Two weeks)
研究者
Orkun Tüfekçi
Principal Investigator, PT, PhD(c)
Hacettepe University