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Muscle WeaknessHIITERGYNCT02318459

High Intensity Interval Training in Geriatrics

A study testing high intensity interval training-HIIT and Traditionnal group rehabilitation in people with Muscle Weakness and Gait, Unsteady, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Muscle Weakness, Gait, Unsteady
What is being tested?
high intensity interval training-HIIT and Traditionnal group rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSwitzerland
Study dates
May 2014to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hôpital des Trois-Chêne (HUG)

    Geneva, Thônex, 1226

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
high intensity interval training-HIIT, Traditionnal group rehabilitation
Medical subject headings
Muscle Weakness, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high intensity interval training-HIITOther

    HIIT 4 times a week, 30 minutes duration

  • Traditionnal group rehabilitationOther

    Traditionnal group rehabilitation, 3 times a week, 1 hour duration

Study groups in NCT02318459
Study groupRoleWhat they receive
high intensity interval training-HIITExperimentalHIIT 4 times a week, 30 minutes duration
Receives: Other: high intensity interval training-HIIT
Traditionnal rehabilitationActive comparatorTraditionnal group rehabilitation 3 times a week, 1 hour duration.
Receives: Other: Traditionnal group rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who complete the rehabilitation program

    Measured: 2 weeks

Secondary outcomes (3)

  1. Distance walked in the 6MWT

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

  3. Step variability changes as a measure of quality of ambulation

    Variability measured with GaitRite step analysis system

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionNov 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318459
Sponsor's protocol ID
13-257
Acronym
HIITERGY
Status last verified
Nov 2016
First submitted
7 Nov 2014
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32503465

Questions about this trial

What is this clinical trial studying?

A study testing high intensity interval training-HIIT and Traditionnal group rehabilitation in people with Muscle Weakness and Gait, Unsteady, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who complete the rehabilitation program (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318459, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

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High Intensity Interval Training in Geriatrics | AzTrials