High Intensity Interval Training in Geriatrics

Muscle Weakness Clinical Trial

— HIITERGY  

Official title:

High Intensity Interval Training for thE Rehabilitation of Geriatric Patients - a Feasibility Pilot studY.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318459
• Other study ID #: 13-257
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: November 2, 2016
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Muscle Weakness
• Paresis

Intervention

Other:
• high intensity interval training-HIIT
HIIT 4 times a week, 30 minutes duration
• Traditionnal group rehabilitation
Traditionnal group rehabilitation, 3 times a week, 1 hour duration

Locations

Country	Name	City	State
Switzerland	Hôpital des Trois-Chêne (HUG)	Geneva	Thônex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who complete the rehabilitation program		2 weeks	Yes
Secondary	Distance walked in the 6MWT		2 weeks	No
Secondary	Muscle strength assessed for the upper and lower extremities	upper extremity : handgrip strength using the Baseline Pneumatic Bulb Hand Dynamometer Pinch Gauge; Lower exremity : knee flexion & extension and ankle flexion & extension using Microfet2™portable Dynamometer.	2 weeks	No
Secondary	Step variability changes as a measure of quality of ambulation	Variability measured with GaitRite step analysis system	2 weeks	No