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出境医 / 临床实验 / High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study

High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Rehabilitation Post-Operative Condition Deconditioning After Acute Hospital Oncology Other: High Intensity Interval Training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 15, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control Group
Patients will participate in regular training units
Active Comparator: HIIT Group
Patients will participate in high intensity interval training
 Other: High Intensity Interval Training
Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.
Outcome Measures
Primary Outcome Measures :
  1. Will there be a change in outcome of individuals vO2max? [ Time Frame: 2 Weeks ]
    Measurement of vO2max with spiroergometer at the beginning and end

  2. Is a High intensity interval training feasible with elderly patients in rehabilitation? [ Time Frame: 1 Day ]
    Questionnaire (Clinic-intern questionnaire) amongst the involved personal


Secondary Outcome Measures :
  1. Will there be a change in subjective quality of life? [ Time Frame: 2.5 Weeks ]
    Questionnaires (PROMIS-10, EQ-5D) amongst the participants


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
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Switzerland
Rehazentrum Walenstadtberg
Walenstadtberg, Switzerland
Sponsors and Collaborators
Klinik Valens
Tracking Information
First Submitted Date  ICMJE June 16, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE July 30, 2019
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Will there be a change in outcome of individuals vO2max? [ Time Frame: 2 Weeks ]
    Measurement of vO2max with spiroergometer at the beginning and end
  • Is a High intensity interval training feasible with elderly patients in rehabilitation? [ Time Frame: 1 Day ]
    Questionnaire (Clinic-intern questionnaire) amongst the involved personal
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		Will there be a change in subjective quality of life? [ Time Frame: 2.5 Weeks ]
Questionnaires (PROMIS-10, EQ-5D) amongst the participants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
Official Title  ICMJE High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Rehabilitation
  • Post-Operative Condition
  • Deconditioning After Acute Hospital
  • Oncology
Intervention  ICMJE Other: High Intensity Interval Training
Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.
Study Arms  ICMJE
  • No Intervention: Control Group
    Patients will participate in regular training units
  • Active Comparator: HIIT Group
    Patients will participate in high intensity interval training
    Intervention: Other: High Intensity Interval Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025385
Other Study ID Numbers  ICMJE KLV-BA-2019-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Kruesi, Klinik Valens
Study Sponsor  ICMJE Klinik Valens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Klinik Valens
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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