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.
調査の概要
詳細な説明
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)
研究の種類
介入
入学 (実際)
19
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alberta
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Calgary、Alberta、カナダ、T2N 1N4
- University of Calgary
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of physical activity program as measured by participant recruitment rate.
時間枠：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.
時間枠：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.
時間枠：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).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nicole r Culos-Reed, PhD、University of Calgary
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年3月2日
一次修了 (実際)
2018年12月20日
研究の完了 (実際)
2018年12月20日
試験登録日
最初に提出
2019年6月6日
QC基準を満たした最初の提出物
2020年3月6日
最初の投稿 (実際)
2020年3月10日
学習記録の更新
投稿された最後の更新 (実際)
2020年3月10日
QC基準を満たした最後の更新が送信されました
2020年3月6日
最終確認日
2020年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。