Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Rate of Participant Enrollment
研究概览
简要总结
The purpose of this study is to explore whether a structured program can help reduce the challenges of decreased physical functioning and quality of life for participants with multiple myeloma by providing a customized exercise program and fostering engagement in meaningful activities.
The name of the study intervention involved in this study is:
Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)
详细描述
The goal of this single arm, pilot study of the Health Through Activity (HTA) rehabilitation intervention for people living with multiple myeloma is to determine if investigators can feasibly deliver the program out of the IMPACT Practice Center at the MGH Institute for Health Professions.
- The six-session 'Health Through Activity' program provides a customized exercise plan and encourages engagement in activities to reduce disability and improve quality of life.
- Study procedures including screening for eligibility, in-clinic visits, questionnaires, and surveys.
- Participation in this research study is expected to last up to 4 months.
It is expected that up to 20 people will take part in this research study.
An internal grant from the Massachusetts General Hospital Institute of Health Professions is providing equipment and staffing for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosed with multiple myeloma currently receiving maintenance therapy,
- •Experiencing disability as indicated by an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"
排除标准
- •Bone pain that is either a) new onset or increased in the past month or b) uncontrolled i.e., in the patient's estimation the bone pain "greatly interferes with daily activities"
- •History of fracture in the past 12 months without fixation, or
- •Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire[29] (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
- •We will also exclude individuals with moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six item cognitive screening tool.
结局指标
主要结局
Rate of Participant Enrollment
时间窗: At screening
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Assessment Completion Rate
时间窗: Up to 4 months
Defined as the number of participants completing each of the three study assessments to number of participants enrolled. A completion rate of 85% will indicate feasibility.
Eligibility Rate
时间窗: Up to 4 months
Number patients screening positive \& eligible / Number screened. Eligibility rate is influenced by how many people in the clinical population are experiencing disability. Based on our pilot study, expected rate to be at least 35%.
Screening Rate
时间窗: Up to 4 months
Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility
次要结局
- Intervention Completion Rate(Up to 3 months)
- Participant Satisfaction(Up to 4 months)
研究者
Kathleen Lyons, ScD, OTR/L
Principal Investigator
MGH Institute of Health Professions