- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025385
High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
March 2, 2021 updated by: Michael Kruesi, Klinik Valens
Study with Patients (40-60 participants) above the age of 65.
There will be a comparison of regular training on ergometer (10 trainings within 2 weeks, 40 min each) to high intensity interval training on ergometer (6 trainings within 2 weeks, 25 min each).
At the beginning and at the end will be a spiroergometer to measure the individual limits and vO2max, which will be compared amongst the two groups.
To receive a subjective feedback, there will be a series of questionnaires at the beginning, after one week and at the end.
The goal of this study is to get more information about whether a HII-Training is feasible with elderly patients and whether they can profit form it.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
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
-
-
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Walenstadtberg, Switzerland
- Rehazentrum Walenstadtberg
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cardiopulmonal resilient
- able to sit on a ergometer
- knowledge of German written and spoken
Exclusion Criteria:
- Severe cardiopulmonary restriction (LVEF <30%, conduction abnormalities from AV block IIb or higher)
- Absolute cardiopulmonary contraindications (acute coronary syndrome, unstable AP -> not capable of rehabilitation), uncompensated heart failure (dyspnea at rest, orthopnea, severe edema)
- No ischemic events (cardiac, cerebral, peripheral) within the last 3 months
- Severe pneumatological underlying disease: COPD GOLD 3 and higher or status after exacerbation within the last 2 weeks, Asthma grade 4
- Dyalisis reliant
- Severe psychiatric disorder (severe psychosis, severe depression)
- Distinct dementia
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Patients will participate in regular training units
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|
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Active Comparator: HIIT Group
Patients will participate in high intensity interval training
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Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Will there be a change in outcome of individuals vO2max?
Time Frame: 2 Weeks
|
Measurement of vO2max with spiroergometer at the beginning and end
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2 Weeks
|
|
Is a High intensity interval training feasible with elderly patients in rehabilitation?
Time Frame: 1 Day
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Questionnaire (Clinic-intern questionnaire) amongst the involved personal
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1 Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Will there be a change in subjective quality of life?
Time Frame: 2.5 Weeks
|
Questionnaires (PROMIS-10, EQ-5D) amongst the participants
|
2.5 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 30, 2019
Primary Completion (Actual)
September 30, 2020
Study Completion (Anticipated)
December 15, 2021
Study Registration Dates
First Submitted
June 16, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLV-BA-2019-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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