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临床试验/NCT04281849
NCT04281849已完成不适用

Pilot Study of a Moderate- to High-Intensity Home-based Rehabilitation Program in Older Adults Hospitalized for Heart Failure: The Balance, Aerobic Capacity, Mobility and Strength (BAMS-HF) Program.

VA Eastern Colorado Health Care System1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Feasibility of recruiting patients into the study

研究概览

简要总结

This is a pilot randomized trial of the BAMS-HF (Balance, Aerobic capacity, Mobility and Strength in patients hospitalized for Heart Failure) Program versus usual care. The BAMS-HF Program pilot study is an initial step in eventually creating a comprehensive, patient-centered, primarily home-based rehabilitation intervention aimed at preventing worsening disability and dependence among older adults hospitalized for HF. The BAMS-HF Program will enroll patients hospitalized for HF (or with HF as an active problem during hospitalization) within the past 4 weeks and will engage patients during the vulnerable post-discharged period. The objective of this pilot study is to test the feasibility, acceptability and preliminary effect of the BAMS-HF Program in older (>/= 65 years) adults hospitalized for HF. The BAMS-HF Program will begin within 4 week of hospital discharge and be administered 3 times weekly for 12 weeks in the patient's home upon discharge. Patients who are able to safely complete the program without in-person assistance will transition to telehealth (aka telerehabilitation) visits. The BAMS-HF Program is innovative because it is home-based, and will utilize rigorous, progressive exercises across multiple domains of physical function. The estimated preliminary effect size will be measured with the Short Physical Performance Battery (SPPB), a well-validated measure that predicts incident mobility/disability and falls in the geriatric population.

Aim #1: To assess the feasibility of the BAMS-HF Program by measuring 1) study enrollment rate, 2) proportion of prescribed sessions that were actually performed, 3) proportion of patients completing full baseline assessment and outcome measures

Aim #2: To assess the acceptability of the BAMS-HF Program with qualitative interviews of participants in the intervention arm that will ask about their experience in the program, any aspects of the intervention they recommend changing and whether patients would recommend the program to others. Reason for declining or stopping participation in the study will also be recorded and considered in adjusting the study protocol.

Aim #3: To estimate the preliminary intervention effect by investigating the difference in change in SPPB between the BAMS-HF Program arm and the usual care arm.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •55 years old or older
  • •Hospitalized for HF or with HF as an active problem during hospitalization
  • •SPPB >/=10

排除标准

  • •Irreversible orthopedic or neurologic disease that severely limits mobility
  • •Active cancer diagnosis except non-melanoma skin cancer
  • •Life expectancy of < 6 months
  • •Uncontrolled/untreated ventricular tachycardia or ventricular fibrillation
  • •Advanced heart failure with expectation of left ventricular assist device or transplant in the next 6 months
  • •Any major surgery in the past 30 days or planned in the next 10 weeks
  • •Discharge to a skilled nursing facility and/or home with home healthcare physical therapy (home health care nurse or occupational therapist is ok)

研究组 & 干预措施

Usual care

No Intervention

Patients in the usual care arm will receive educational material from the Heart Failure Society of America (HFSA) with the current recommendations for exercise for patients with heart failure.

BAMS-HF Program

Experimental

干预措施: BAMS-HF Program (Behavioral)

结局指标

主要结局

Feasibility of recruiting patients into the study

时间窗: Monthly, up to 30 months

Number of patients enrolled in the study each month

Acceptability of the intervention to patients randomized to the intervention arm

时间窗: At the end of the intervention period for each patient (week 12 or at time of study dropout)

Qualitative interviews of participants in the intervention arm will ask about their experience in the program, any aspects of the intervention they recommend changing and whether patients would recommend the program to others. Reason for declining or stopping participation in the study will also be recorded and considered in adjusting the study protocol.

Feasibility of the protocol for patients randomized to the intervention arm

时间窗: At the end of the intervention period for each patient (week 12 or at time of study dropout)

Proportion of prescribed sessions that were actually performed

次要结局

  • Change in Short Physical Performance Battery, which is scored from 0-16, with higher numbers indicating better functional status(At the end of 12 weeks of study enrollment for each patient)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Kelsey Flint

Staff Cardiologist

VA Eastern Colorado Health Care System

研究点 (1)

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