NCT05562037Completed
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 139 (actual)
- First submitted
- 3 Aug 2022
- Start date
- 8 Sept 2022
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Peter Lindenauer, MD
- Diseases
- Heart failure, Coronary artery disease, COPD
- NCT number
- NCT05562037
What you commit to
- Study type: Interventional
- Participants enrolled: 139
- From 8 Sept 2022 to the primary completion date, 30 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Attended pulmonary or cardiac rehabilitation within the previous two years
- Unstable asthma with hospital admission or ED visit within previous three months
- Planned surgery or transplantation
Other illness
- Acute systemic illness or fever
- Complex ventricular arrhythmias
- History of arrhythmia with syncope
- Severe symptomatic valvular disease
- Unstable angina
- Uncontrolled atrial or ventricular arrhythmias
- Uncompensated congestive heart failure
- Third degree heart block without a pacemaker
- Acute cor pulmonale, severe pulmonary hypertension
- Conditions other than pulmonary or cardiac that prohibit exercise (e.g., arthritis, severe neurologic, hepatic or renal disease)
- Hearing impairment limiting ability to participate in data collection by telephone
- 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
Lab values
- Uncontrolled diabetes (resting blood glucose \>400 mg/dl)
Other
- Resting pulse oximetry \< 85% on room air or while breathing the prescribed level of supplemental oxygen
- Severe exercise-induced hypoxemia, not correctable with oxygen supplementation
- 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
- Uncontrolled sinus tachycardia (\>120 BPM)
- Active pericarditis or myocarditis
- Resting ST displacement \> 2mm
- Life expectancy less than one year
Who the study is looking for
- 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)
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Berkshire Medical Center, Inc Coordinator of this site? Confirm its status | Pittsfield | United States | Unknown status |
| Baystate Health Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.