Feasibility and Efficacy of the Remotely Delivered STABLE Program for Community-dwelling Older Adults With Cancer: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Fall assessment
研究概览
简要总结
Falls are a major health concern amongst older adults with cancer, and are often related to decreased physical strength due to effects of cancer and its treatments. Ample evidence demonstrates the benefits of exercise programs incorporating strength and balance training on lower body strength, balance, and fall prevention older adults. However, gaps in research exist within the geriatric oncology context. The purpose of this study is to determine the feasibility and efficacy of a 3-month, remotely delivered exercise program regimen on lower body strength, balance, and falls in older adults with cancer.
This observer-blinded, randomized controlled feasibility trial aims to recruit older cancer patients (aged ≥65). Participants in the intervention group will undertake the exercise program 3 times weekly for three months. Data collection will include sociodemographic survey, baseline, end-of-intervention (3-month) assessment, follow-up (6-month) assessment, chart review, and exit survey. Descriptive and inferential statistics will be used to analyze data, following the intention-to-treatment principle.
Data generated from this research project will inform design of a subsequent, larger exercise intervention trial. This is an important step to establish the knowledge base regarding provision of exercise interventions as a fall prevention strategy to reduce falls and their negative outcomes in older patients in the community.
详细描述
Hypothesis: A remotely delivered, 3-month resistance and balance training program will result in an increase in lower body strength, improvement in balance, as well as a lower fall rate compared to control. This is important because of the potential to improve quality of life for older adults with cancer, decreasing societal and economic costs associated with injuries and injury-related treatment and hospitalizations, and avoiding unnecessary modifications to cancer treatment.
Objectives
- Determine the feasibility of a remotely delivered resistance and balance training program over a 3-month period in community-dwelling older adults (≥65 years of age) who have undergone or are receiving systemic cancer treatment; and
- Explore the efficacy of this exercise program on lower body strength, balance, and fall rates and obtain estimates to inform the design of a larger randomized controlled trial.
METHOD:
The STABLE (Strength Training And Balance Leg Exercise) study is an observer-blinded, parallel group (IG vs. CG) randomized controlled trial. Participants Study participants will be recruited over a 12-month period from the cohort of older patients with cancer referred to the Cross Centre Institute, Edmonton, Alberta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors who collect outcome data will be blinded to group allocation. Participants will be advised to refrain from disclosing their group allocation to the outcome assessor.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 65 or above;
- •living in the community;
- •have a confirmed diagnosis of any stage of lung, breast, prostate, or colorectal cancer; - currently receiving, starting or have completed systemic anti-cancer therapy;
- •life-expectancy of at least 9 months (in consideration of the measurement period of the study and also avoid burdening patients who are near the end-stage of their disease); and - completed the PAR-Q screening or have approval of their treating physician.
排除标准
- •presence of brain metastases;
- •presence of unstable metastases as per treating physician (e.g., bone metastasis in a weight-bearing area, recent bone fracture);
- •presence of any conditions that would potentially interfere with their ability to carry out the exercise interventions (e.g., mobility impairment, poorly controlled pain, severe vision/hearing loss, severe arthritis that limits ambulation, left-sided heart failure, neurological or musculoskeletal conditions);
- •self-reported history of light-headedness during physical activities; syncopal episodes within the past month; and
- •participation in any form of structured exercise program (that are at least 30 minutes per week) at the time of consent.
研究组 & 干预措施
Control group
Participants in the CG will not receive the intervention, and will be advised to carry out their usual daily activities.
Intervention group
Participants in the IG will receive the STABLE intervention, which entails orientation, and undertaking a remotely delivered resistance and balance training regimen 3 times weekly for 3 months
干预措施: Strength and balance exercise (Other)
结局指标
主要结局
Fall assessment
时间窗: Baseline, 3 & 6 months - to measure change
Falls will be assessed at t0, t1, and t2 as described, by self-report following recommendations of fall assessment as outlined by the American Geriatrics Society/British Geriatrics Society (AGS/BGS)
Balance test
时间窗: Baseline, 3 & 6 months - to measure change
Static balance ability will be measured using the Side-by-side Stand (SBS), Semi-tandem Stand (ST), and Full tandem Stand (FT). Participants will be asked to maintain their balance in the three different positions. The amount of time they succeed in maintaining the various positions, in seconds, will be recorded based on the following criteria: Side-by-side 10 sec, semi-tandem 10 sec (1 point); tandem 10 sec (2 points), tandem 3-9.99 second (1 point).
30-second Chair Stand test
时间窗: Baseline, 3 & 6 months - to measure change
The 30-second chair stand test will begin with having the participating sitting upright in the middle of the chair with arms folded across the chest with hands placed on the front of the opposite shoulder. The feet are placed flat on the ground at shoulder width and slightly behind the knee. At the initiation of the test using a count down of "ready...go," the participant will stand upright (knees straight and torso fully erect) while maintaining the hand position on the shoulder and then return to a fully seated position in which body weight is shifted from the feet to the chair. The participant will complete as many stand-sit cycles as possible in the 30-second period. The number of sit-to-stands completed within the 30 seconds will be recorded and interpreted based on age group and gender as recommended by the Centers for Disease Control and Prevention STEADI guideline.
次要结局
未报告次要终点
研究者
Schroder Sattar
Assistant Professor
University of Saskatchewan