Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
CompletedNot applicableNCT05562037
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This feasibility trial will focus on older adults 60+ who are candidates for cardiac or pulmonary rehabilitation and who are vulnerable, mildly or moderately frail. The investigators will randomize older frail adults living in rural regions of the county to Treatment as usual (TAU) or Stepped care (SC). TAU refers to center-based rehabilitation (CBR). Patients randomized to SC will be enrolled in traditional CBR and based on prespecified non-response criteria, will step up to three services: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR.
Study details
- Official title
- Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
- Conditions
- Angina, Stable
- Congestive Heart Failure
- Chronic Obstructive Pulmonary Disease
- Interventions
- Other: Stepped Care
- Sponsor
- Peter Lindenauer, MD
- Collaborators
- Berkshire Medical Center
- Organization
- Baystate Medical Center
- Start date
- 2022-09-08
- Primary completion
- 2025-03-30
- Sex
- All
- Age range
- from 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Older adults (greater than 60 years of age) * Live in a Level 1 or 2 state designated rural area in Berkshire County * Has a condition qualifying for reimbursement (by government or private insurance) for cardiac or pulmonary rehabilitation * Score of 4, 5 or 6 on the Clinical Frailty Scale(24) (corresponding to vulnerable, mildly frail, and moderately frail) Exclusion Criteria: Attended pulmonary or cardiac rehabilitation within the previous two years * Resting pulse oximetry \< 85% on room air or while breathing the prescribed level of supplemental oxygen * Unstable asthma with hospital admission or ED visit within previous three months * Severe exercise-induced hypoxemia, not correctable with oxygen supplementation * Acute systemic illness or fever * Complex ventricular arrhythmias * Resting systolic blood pressure greater than 200mmhg * Resting diastolic blood pressure greater than 100mmhg * Orthostatic blood pressure (BP) drop of \>20 mm Hg with symptoms * History of arrhythmia with syncope * Severe symptomatic valvular disease * Unstable angina * Uncontrolled atrial or ventricular arrhythmias * Uncontrolled sinus tachycardia (\>120 BPM) * Uncompensated congestive heart failure * Third degree heart block without a pacemaker * Active pericarditis or myocarditis * Acute cor pulmonale, severe pulmonary hypertension * Resting ST displacement \> 2mm * Uncontrolled diabetes (resting blood glucose \>400 mg/dl) * Conditions other than pulmonary or cardiac that prohibit exercise (e.g., arthritis, severe neurologic, hepatic or renal disease) * Planned surgery or transplantation * Hearing impairment limiting ability to participate in data collection by telephone * Life expectancy less than one year * Significant cognitive deficit and/or psychiatric illness that interferes with ability to provide consent, follow directions, or adhere to study procedures * referral to cardiac rehab after coronary artery bypass graph (CABG) and valvular surgery
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05562037