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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04025385
Other study ID # KLV-BA-2019-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 30, 2019
Est. completion date December 15, 2021

Study information

Verified date March 2021
Source Klinik Valens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 15, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High Intensity Interval Training
Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.

Locations

Country Name City State
Switzerland Rehazentrum Walenstadtberg Walenstadtberg

Sponsors (1)

Lead Sponsor Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Will there be a change in outcome of individuals vO2max? Measurement of vO2max with spiroergometer at the beginning and end 2 Weeks
Primary Is a High intensity interval training feasible with elderly patients in rehabilitation? Questionnaire (Clinic-intern questionnaire) amongst the involved personal 1 Day
Secondary Will there be a change in subjective quality of life? Questionnaires (PROMIS-10, EQ-5D) amongst the participants 2.5 Weeks
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