- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02318459
High Intensity Interval Training in Geriatrics (HIITERGY)
November 2, 2016 updated by: Jean-Luc Reny, University Hospital, Geneva
High Intensity Interval Training for thE Rehabilitation of Geriatric Patients - a Feasibility Pilot studY.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thônex
-
Geneva, Thônex, Switzerland, 1226
- Hôpital des Trois-Chêne (HUG)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: high intensity interval training-HIIT
HIIT 4 times a week, 30 minutes duration
|
HIIT 4 times a week, 30 minutes duration
|
|
Active Comparator: Traditionnal rehabilitation
Traditionnal group rehabilitation 3 times a week, 1 hour duration.
|
Traditionnal group rehabilitation, 3 times a week, 1 hour duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of patients who complete the rehabilitation program
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distance walked in the 6MWT
Time Frame: 2 weeks
|
2 weeks
|
|
|
Muscle strength assessed for the upper and lower extremities
Time Frame: 2 weeks
|
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
|
|
Step variability changes as a measure of quality of ambulation
Time Frame: 2 weeks
|
Variability measured with GaitRite step analysis system
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Luc Reny, MD, PhD, Hôpitaux Universitaires de Genève
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
November 7, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 17, 2014
Study Record Updates
Last Update Posted (Estimate)
November 3, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-257 (Other Identifier: University of Central Florida)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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