Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quality of life measure
研究概览
简要总结
The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease.
The specific aims of the study are:
- To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.
- To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation.
Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.
详细描述
Random Assignment Participants will be randomly assigned using a web-based randomization service (www.randomize.net) to one of three groups: 1) tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) onsite outpatient rehabilitation, and 3) control group, using a computerized random number generator to eliminate risk of bias during allocation.
Subject Enrollment Consent: Potential participants who express interest in the study will be contacted via a phone call by the study team to go over screening and to seek consent for the study. Pre-screening questions will be asked over the phone to confirm eligibility. The letter of informed consent will be read out during the initial phone call and participants will be asked to sign a copy of the consent form prior to their initial visit at the IMPACT Practice Center at MGH Institute of Health Professions via a RedCap link sent to their email. Any questions related to the study will be answered prior to getting a signature on the consent form (See attached consent form). Participants will be informed of the possibility of being in one of three groups. The study Investigators will be involved in obtaining consent. Control group participants will be offered an opportunity to complete an 8-week onsite or tele-rehab intervention upon completion of the study duration. Participants will be able to withdraw from the study at any point with no penalties or any negative consequences. Participation will be voluntary, and participants can choose to step out of the study at any time.
To enhance enrollment of participants from diverse and under-represented backgrounds, free parking will be provided to the onsite location at MGH Institute of Health Professions. For participants assigned to the tele-rehab group, who do not have the means to connect and participate in the intervention, will be loaned an I-pad for the duration of the study. In addition, all participants will be provided with a $50.00 gift card at the end of the study period for their participation in the study.
6. STUDY PROCEDURES
Following informed consent, all participants will undergo a baseline assessment at index date or time point 0. Since the recruitment will occur on a rolling basis, the time 0 will vary for participants.
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
All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients 40 years and older with physician diagnosed Chronic Lung Disease within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition
- •Able to walk independently with or without mobility devices
- •Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85%
- •Able to follow commands and instructions in the English language
- •Have ability to connect to the internet
排除标准
- •• Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device.
- •Patients who primarily rely on a wheelchair for mobility
- •Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation
- •Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs)
- •Inability to communicate in the English language
结局指标
主要结局
Quality of life measure
时间窗: At 4- month follow up
Quality of life measured by the chronic obstructive pulmonary disease Assessment Test (CAT) scale. Score ranges from 0-40, with higher scores indicating a more severe impact on a patient's life
Physical Function
时间窗: At 4 months follow up
Physical function measured by the 30 seconds chair rise test
Exercise Capacity
时间窗: At 4 months follow up
Exercise capacity as measured by the six-minute walk distance
Dyspnea
时间窗: At 4 months follow up
Dyspnea measured on the modified Medical Research Council (mMRC) scale score ranges from 0-4 with higher scores indicating greater shortness of breath
次要结局
- Healthcare utilization(8 weeks)
- Adverse events(8 weeks)
- Inspiratory muscle strength(At 8 weeks (end of the study))
- Participants adherence to the program(8 weeks)
- Physical activity(At 4 months follow up)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 score(At 4-month follow up)
研究者
Shweta Gore
Associate Professor
MGH Institute of Health Professions