免费获得国外相关药品，最快 1 个工作日回馈药物信息
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
| 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 :
- 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
Secondary Outcome Measures :
- 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
| 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
| 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 |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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 |
|
||||
| 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 |
|
||||
| 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 |
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:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| 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 |
|
||||
| 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 |
|||||
