The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
2020年3月6日 更新者：Dr. Nicole Culos-Reed
Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients
Although physical activity (PA) is commonly used to manage symptoms and enhance quality of life (QOL) in cancer survivors, relatively little is known regarding the benefits in advanced multiple myeloma (MM).
The primary aims of the Physical Activity in Advanced Cancer Treatment (PAACT) intervention were to examine (1) program feasibility and (2) potential impact on patient outcomes.
It is hypothesized that an exercise intervention will be feasible and potentially impactful.
研究概览
详细说明
While the introduction of novel and more effective treatments has seen improved survival in multiple myeloma (MM), the aggressive nature of the disease and these corresponding agents can have a debilitating impact on quality of life (QOL).
Exercise can help manage symptoms and enhance QOL in cancer survivors, however relatively little is known regarding the feasibility or benefits of exercise in MM.
The purpose of this study was to examine the feasibility of a group- and home-based exercise intervention for individuals with advanced MM.
In this single arm study, advanced MM patients (DS stage II-III) participated in a 12-week aerobic and resistance training intervention, with the option of palliative care consultation.
Participants attended once weekly supervised group exercise classes and received individually tailored home exercise booklets.
Validated measures of physical functioning and patient-reported outcomes, including QOL, fatigue, anxiety, depression, and self-compassion were obtained at baseline and 12-weeks (post-intervention).
Optional semi-structured interviews were conducted halfway (week 6) and at the end of the intervention (week 12)
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 1N4
- University Of Calgary
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- diagnosed with advanced (Durie-Salmon stage II-III) multiple myeloma
- 18 years of age or older and given a survival prognosis greater than 6 months
- stable hemoglobin level of ≥80g/L as measured within 2 weeks of enrollment
- no active infections at the time of enrollment.
Exclusion Criteria:
- refusal of informed consent
- geographically inaccessible
- non-English speaking
- co-morbidities that interfere with participation (i.e., severe mobility issues or cognitive impairments)
- known or active history of substance abuse
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Exercise group
Single-arm study.
Participants enrolled engaged in a 12-week exercise program.
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12-week physical activity intervention.
60 minute group-based exercise classes held once per week.
Home-based exercise recommendations provided weekly along with basic take-home exercise equipment.
Optional palliative care consultations offered.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of physical activity program as measured by participant recruitment rate.
大体时间：3 months
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Recruitment as defined by the proportion of patients who participate in the study, out of the total number of eligible patients.
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3 months
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Feasibility of physical activity program as measured by attendance of group exercise classes.
大体时间：12-weeks
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Attendance is defined by the number of weekly group-exercise classes attended.
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12-weeks
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Feasibility of physical activity program as measured by attrition rate.
大体时间：12-weeks
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Attrition is defined as the number of participants who dropped out of the program after completing the baseline assessment.
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12-weeks
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Feasibility of physical activity program as measured by safety (as measured by incidence of patient reported adverse events).
大体时间：12-weeks
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Safety is described as any adverse event reported by the participants during the 12-week program or fitness assessments, related to program participation.
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12-weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline Upper Body Muscular Strength (in kilograms) as measured by a grip strength test using a hand dynamometer at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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Total grip strength in kilograms is recorded as the sum from the best score of two trials recorded for each hand.
Differences between baseline and post-intervention assessments are evaluated.
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Baseline (week 0) and 12 weeks
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Change from Baseline Functional lower body strength (in number of repetitions) as measured by the Chair stand test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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Chair stand test records the number of times a participant can stand from a seated position in 30 seconds.
Differences between baseline and post-intervention assessments are evaluated.
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Baseline (week 0) and 12 weeks
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Change from Baseline Lower Body Flexibility (in centimeters) as measured by the Chair Sit and Reach flexibility test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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In the Chair Sit and Reach Flexibility test, lower body flexibility is assessed by having the participant sit on the edge of a seat.
The participant extends the leg being tested in front of the hip, with the heel on the floor and the ankle dorsiflexed approximately 90 degrees.
The participant flexes the untested leg so that the sole of the foot is flat on the floor about 6 to 12 inches to the side of the body's midline.
With the extended leg as straight as possible and the hands on top of each other (palms down), the participant slowly bends forward at the hip joint, keeping the spine as straight as possible and the head in normal alignment (not tucked) with the spine.
The participant reaches down the extended leg, trying to touch the toes, and holds this position for 2 sec.
A ruler is ran parallel to the participant's lower leg.
Two practice trials are allowed followed by two test trials.The best measurement is taken.
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Baseline (week 0) and 12 weeks
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Change from Baseline Upper Body Flexibility (in centimeters) as measured by the Back-Scratch Flexibility test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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In the Back-Scratch Flexibility test, upper body flexibility is assessed by asking the participant to reach, with the preferred hand (palm down and fingers extended), over the shoulder and down the back while reaching around and up the middle of the back with the other hand (palm up and fingers extended).
The participant is allowed two practice trials followed by two test trials.The best measurement is taken.
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Baseline (week 0) and 12 weeks
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Change from Baseline Mobility (in seconds) as measured by the 8-foot Timed Up and Go test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The 8-foot Timed Up and Go test measures the time to move from a seated position, walk 8 feet, and return to a seated position.The best of two trials is taken.
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Baseline (week 0) and 12 weeks
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Change from Baseline Balance (in seconds) as measured by a one-foot balance test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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Participant's Balance is assessed by measuring the time the participant is able to stand on one-foot.
Both feet measured.
A 45-second cut-off time is implemented.
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Baseline (week 0) and 12 weeks
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Change from Baseline Aerobic Capacity (in meters) as measured by the six-minute walk test at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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In the Six-Minute Walk Test, participants are instructed to walk as far as they can for 6 min around a track.
Distances are recorded to the nearest 0.5 m.
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Baseline (week 0) and 12 weeks
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Change from Baseline Quality of Life as measured by the The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire is comprised of the 27-item FACT-General (FACT-G) scale, which provides information on physical, social, emotional, and functional well-being domains in conjunction with 14 MM-specific supplementary questions.
The combined subscales of physical, functional, and MM specific domains contribute to the Trial Outcome Index (TOI) score (range of 0-112).
The questionnaire is rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing improved quality of life.
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Baseline (week 0) and 12 weeks
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Change from Baseline Fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire is a13-item questionnaire rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing decreased fatigue.
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Baseline (week 0) and 12 weeks
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Changes from Baseline Anxiety as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale.
Subscales for anxiety were calculated with a range of 0-21, with low scores (0-7) representing normal levels.
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Baseline (week 0) and 12 weeks
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Changes from Baseline Depression as measured by the Hospital Anxiety and Depression Scale (HADs) questionnaire at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale.
Subscales for depression were calculated with a range of 0-21, with low scores (0-7) representing normal levels.
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Baseline (week 0) and 12 weeks
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Changes from Baseline Self-compassion as measured by the Self-Compassion Scale (SCS) at 12-weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Self-Compassion Scale (SCS) is a 26-item scale.
The following subscales are measured on a 5-point Likert scale (1 = almost never to 5= almost always): self- kindness, self-judgment, common humanity, isolation, mindfulness and over-identified items.
In this study a grand mean representing an overall measure of self-compassion willl be calculated, with a higher score representing higher levels of self-compassion.
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Baseline (week 0) and 12 weeks
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Changes from Baseline Physical Activity Levels as measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ) at 12 weeks.
大体时间：Baseline (week 0) and 12 weeks
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The Godin Leisure Time Exercise Questionnaire (GLTEQ) assesses current physical activity levels.
Participants report on the duration and frequency of mild, moderate, and strenuous PA within a typical week over the past month.
Total weekly physical activity is calculated.
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Baseline (week 0) and 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nicole r Culos-Reed, PhD、University Of Calgary
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月2日
初级完成 (实际的)
2018年12月20日
研究完成 (实际的)
2018年12月20日
研究注册日期
首次提交
2019年6月6日
首先提交符合 QC 标准的
2020年3月6日
首次发布 (实际的)
2020年3月10日
研究记录更新
最后更新发布 (实际的)
2020年3月10日
上次提交的符合 QC 标准的更新
2020年3月6日
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.