A Resistance Training Program to Improve Physical Function in Sarcoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frequency of Related Serious Adverse Events (SAEs)
研究概览
简要总结
This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an independent lifestyle. Engaging in a resistance training exercise routine may improve physical function, body composition, and bone density of sarcoma survivors.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of a home-based individualized progressive resistance training (PRT) program in sarcoma survivors.
SECONDARY OBJECTIVES:
I. To assess secondary measures of feasibility of a home-based, individualized PRT program in sarcoma survivors.
II. To determine if a 3-month PRT program improves physical function in sarcoma survivors.
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
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for the Sarcoma Survivorship Registry (Institutional Review Board [IRB] #12039)
- •History of histologically-confirmed sarcoma
- •History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis
- •Completion of sarcoma treatment >= 2 years prior to study enrollment
- •No evidence of recurrent or residual disease on surveillance exam or imaging for at least 2 years prior to study enrollment
- •Sarcoma location must have been in the extremities, body wall, pelvic/shoulder girdle or axial skeleton. Intra-thoracic, intra-abdominal or cranial sarcomas are not eligible
- •Currently engaging in < 1 hour of resistance exercise per week by self-report. Examples of resistance exercise include: using free weights or weight machines, push-ups, sit-ups, lunges, plank, etc.
- •Able and willing to commit to attending weekly video coaching sessions and independently completing weekly resistance training sessions. This requires access to internet and a device with video and audio capabilities. A webcam may be provided by the study to the participant if needed
- •Able and willing to commit to attending one initial in-person training session and one in-person follow-up assessment
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Medical contraindication(s) to any and all resistance training as determined by treating physician
- •Non-English speaking. At this time, we do not have resources to support translation of exercise physiologist (EP) sessions
- •Dependent on a mobility device (e.g., crutches, wheelchair) for independent activities of daily living (IADLs)
- •Use of a cane is permitted
- •Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results (e.g., pregnancy)
研究组 & 干预措施
Supportive Care (resistance training, exercise counseling)
Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.
干预措施: Exercise Counseling (Other)
Supportive Care (resistance training, exercise counseling)
Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (resistance training, exercise counseling)
Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.
干预措施: Questionnaire Administration (Other)
Supportive Care (resistance training, exercise counseling)
Patients complete a series of progressive resistance training exercises at home twice weekly over 1 hour and receive instructional guidance from an exercise physiologist via videoconferencing once per week during one of these sessions for up to 12 weeks.
干预措施: Resistance Training (Other)
结局指标
主要结局
Frequency of Related Serious Adverse Events (SAEs)
时间窗: From the time of enrollment up to completion of 12 week exercise intervention
Number of participants that experienced exercise-related SAEs
Retention
时间窗: From the time of enrollment up to 3 months end-of-intervention assessments
Number of evaluable participants who completed end-of-intervention assessments
Exercise Adherence
时间窗: From the time of enrollment up to completion of 12 week exercise intervention
Number of participants who completed end-of-intervention assessments and completed at least 18 of 24 prescribed training sessions.
次要结局
- Change in Gait and Balance(Baseline up to completion of 12 week exercise intervention)
- Change in Short Form-36 Physical Function Score(Baseline up to completion of 12 week exercise intervention)
- Difference in 1-repetition Maximum (Kilogram)(Baseline up to completion of 12 week exercise intervention)
- Change in Instrumented Timed up and go Test(Baseline up to completion of 12 week exercise intervention)
- Individualized Progressive Resistance Training (PRT) Prescriptions(From the time of enrollment up to completion of 12 week exercise intervention)
- Change in Godin Leisure-Time Exercise Questionnaire Physical Activity Score (GLTEQ)(Baseline up to completion of 12 week exercise intervention)
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue Score (FACT-F)(Baseline up to completion of 12 week exercise intervention)
- Change in Instrumented Postural Sway(Baseline up to completion of 12 week exercise intervention)
- Mean Patient-Reported Outcomes Measurement Information System (PROMIS) - Cancer Physical Function Score Value(Baseline up to completion of 12 week exercise intervention)
- Change in Short Physical Performance Battery Score(Baseline up to completion of 12 week exercise intervention)
- Change in Grip Strength (Kilogram)(Baseline up to completion of 12 week exercise intervention)
- Change in Instrumented 6-minute Walk Test(Baseline up to completion of 12 week exercise intervention)
研究者
Lara Davis
Principal Investigator
OHSU Knight Cancer Institute