Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
研究概览
简要总结
The goal of this clinical trial is to learn if optimised protein intake improves household work capacity and overall functional status in women with rheumatoid arthritis. It will also assess the safety and tolerability of dietary protein supplementation. The main questions it aims to answer are:
Does optimised protein intake reduce household work limitations measured by the Household Work Limitations Questionnaire (HOWL-Q)?
Does optimised protein intake improve overall functional disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)?
What side effects or tolerability issues do participants experience with dietary protein modification and supplementation?
Researchers compared participants receiving structured dietary counselling and protein supplementation (targeting 1.0 g/kg/day) to their baseline protein intake to determine if the intervention improves functional outcomes in women with stable rheumatoid arthritis on disease-modifying antirheumatic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label, unmasked study. Participants were aware they were receiving dietary counselling and protein supplementation. Care providers administered the intervention openly. Investigators and outcomes assessors were not blinded to group assignment. No blinding was possible due to the nature of the dietary intervention.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged equal to or more than 18 years with rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria
排除标准
- •Unstable disease requiring DMARD modification during the study period
- •Overlap connective tissue disease
- •Chronic kidney disease stage 3 or above
结局指标
主要结局
Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
时间窗: 12 weeks
Household Work Limitations measured using Household Work Limitations Questionnaire (HOWL-Q). A 41-item instrument assessing functional limitations across five domains: housekeeping, object interaction, care for others, personal motion and transportation, and manual dexterity. Each item scored 0-3; domain scores calculated as highest item score per domain; global HOWL-Q score transformed to 0-10 scale (0=best, 10=worst). Primary outcome: change from baseline to 12 weeks. HOWL-Q captures household-specific functional limitations not measured by generic disability scales (HAQ-DI), directly relevant to women's household responsibilities and quality of life.
Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
时间窗: 12 weeks
Overall Functional Disability measured using Health Assessment Questionnaire-Disability Index (HAQ-DI). An 8-domain self-report instrument measuring disability across dressing, arising, eating, walking, hygiene, reach, grip, and activities of daily living. Each domain scored 0-3; final score calculated as mean of eight domains (range 0-3), with lower scores indicating better function. Minimally clinically important difference 0.22 points. Primary outcome: change from baseline to 12 weeks. HAQ-DI demonstrates excellent test-retest reliability (intraclass correlation \>0.95) and internal consistency (Cronbach's alpha \>0.90), established as standard functional disability measure in rheumatoid arthritis research.
次要结局
未报告次要终点