Clinical trial NCT02318459: High Intensity Interval Training in Geriatrics
Official title: High Intensity Interval Training for thE Rehabilitation of Geriatric Patients - a Feasibility Pilot studY.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Gait, Unsteady
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a pilot study for evaluating the feasibility of using High Intensity Interval Training in geriatric hospitalized patients compared to the standard current rehabilitation practice.

Detailed description: High Intensity Interval Training (HIIT) has shown a superior effectiveness and efficiency when compared to Moderate Intensity Continuous Training (MICT) in several types of patients and in healthy subjects. There are no data on HIIT in a general geriatric population. This study is a pilot study evaluating the feasibility of using HIIT in geriatric hospitalized patients compared to the standard current rehabilitation practice without HIIT. It is our desire to perform a larger randomized comparative trial between HIIT and MICT if the pilot study proves its feasibility.

Eligibility criteria: Inclusion Criteria:

* Patients aged 65 years and older hospitalized for rehabilitation after an acute medical condition
* Expected duration of the rehabilitation ≥ 2 weeks
* Ability to follow instructions to perform a Timed up and Go Test
* Ability to perform exercises
* Willing to participate in 4 sessions of HIIT per week for 2 weeks

Exclusion Criteria:

* Any acute condition with tachycardia, hypotension or fever.
* Abnormal cycle ergometer stress test with
* significant ECG modification
* decrease of more than 20 mmHg of the blood pressure with exercise
* angina
* ST depression at a workload \<6 METs
* Inability to reach an intensity of 15/20 in the Borg's scale of perceived exertion
* Any unresolved acute medical or surgical condition of the following kind:
* acute heart failure
* acute coronary syndrome \< 1 month
* strole \< 1 month
* active pericarditis / myocarditis / endocarditis
* thromboembolic disease with \< 2 weeks of anticoagulation
* acute infection requiring intravenous treatment
* ongoing intravenous perfusion
* surgery \< 2 months
* recent bone fracture
* Previous episode of primary cardiac arrest (ie, cardiac arrest that did not occur in the presence of an acute myocardial infarction or during a cardiac procedure).
* Severe heart failure (NYHA III and IV)
* Severe stenotic or regurgitant valvular disease
* Uncontrolled hypertension at rest (SBP≥160mmHg, DBP≥100mmHg)
* Uncontrolled dysrhythmia
* Non-sustained ventricular tachycardia with exercise
* Implanted defibrillator
* Obstructive cardiomyopathy
* Resting HR \> 100/min
* Severe peripheral artery disease
* Severe COPD (VEMS \< 50%)
* Exercise-induced asthma
* Oxygen dependency
* Muscular-skeletal anomaly that may limit exercise participation
* Delirium
* Inability to follow instructions
* Inability to consent

Primary outcomes:
measure: Proportion of patients who complete the rehabilitation program
timeFrame: 2 weeks
Secondary outcomes:
measure: Distance walked in the 6MWT
timeFrame: 2 weeks
measure: Muscle strength assessed for the upper and lower extremities
timeFrame: 2 weeks
measure: Step variability changes as a measure of quality of ambulation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpital des Trois-Chêne (HUG)
state: Thônex
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Luc Reny, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pires Peixoto R, Trombert V, Poncet A, Kizlik J, Gold G, Ehret G, Trombetti A, Reny JL. Feasibility and safety of high-intensity interval training for the rehabilitation of geriatric inpatients (HIITERGY) a pilot randomized study. BMC Geriatr. 2020 Jun 5;20(1):197. doi: 10.1186/s12877-020-01596-7.