Table 1 Exclusion criteria

Unable or unwilling to give informed consent or communicate with local study staff

Current diagnosis of psychiatric disorder or hospitalization for depression in the past 6 months

Self-reported alcohol or substance abuse within the past 12 months

Self-reported inability to walk 2 blocks

Musculoskeletal disorders or deformities that may interfere with participation in the intervention

History of central nervous dysfunction such as hemiparesis, myelopathies, or cerebral ataxia

Clinical evidence of vestibular dysfunction

Postural hypotension defined as a fall in BP when changing position of >20 mmHg (systole) or >10 mmHg (diastole)

Currently pregnant or nursing

Cancer requiring treatment in the past 5 years, except for cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (for example, stage 1 cervical cancer)

Chronic obstructive pulmonary disease

End-stage liver disease;

Chronic diabetic complications:

 • recent major acute cardiovascular event, including heart attack or stroke/transient ischemic attack(s), revascularization procedure, or participation in a cardiac rehabilitation program within the past 3 months

 • pre-proliferative and proliferative retinopathy

 • macroalbuminuria and/or eGFR < 45 ml/min/1.73 m²

 • severe motor and sensory neuropathy

 • diabetic foot with history of ulcer

 • Cardiovascular disease at cardiologic examination:

 • history of cardiac arrest

 • history of pulmonary embolism in the past 6 months

 • unstable angina pectoris or angina pectoris at rest

 • resting HR <45 beats/min or >100 beats/min

 • complex ventricular arrhythmia at rest or with exercise

 • uncontrolled atrial fibrillation (HR ≥100 beats/min)

 • NYHA Class III or IV congestive heart failure

 • acute myocarditis, pericarditis or hypertrophic myocardiopathy

 • left bundle branch block or cardiac pacemaker

Conditions not specifically mentioned above at the discretion of the clinical site