NCT02318459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

November 7, 2014

Last Update Submit

November 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who complete the rehabilitation program

    2 weeks

Secondary Outcomes (3)

  • Distance walked in the 6MWT

    2 weeks

  • Muscle strength assessed for the upper and lower extremities

    2 weeks

  • Step variability changes as a measure of quality of ambulation

    2 weeks

Study Arms (2)

high intensity interval training-HIIT

EXPERIMENTAL

HIIT 4 times a week, 30 minutes duration

Other: high intensity interval training-HIIT

Traditionnal rehabilitation

ACTIVE COMPARATOR

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

Other: Traditionnal group rehabilitation

Interventions

HIIT 4 times a week, 30 minutes duration

high intensity interval training-HIIT

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

Traditionnal rehabilitation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Trois-Chêne (HUG)

Geneva, Thônex, 1226, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscle WeaknessGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jean-Luc Reny, MD, PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of division, Internal medicine and rehabilitation Trois-Chêne

Study Record Dates

First Submitted

November 7, 2014

First Posted

December 17, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations