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

Sponsor

Klinik Valens (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04025385

Collaborator

(none)

Enrollment

Location

Arms

28.6

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 30, 2019

Actual Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Dec 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.

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? [2 Weeks]
Measurement of vO2max with spiroergometer at the beginning and end
Is a High intensity interval training feasible with elderly patients in rehabilitation? [1 Day]
Questionnaire (Clinic-intern questionnaire) amongst the involved personal

Secondary Outcome Measures

Will there be a change in subjective quality of life? [2.5 Weeks]
Questionnaires (PROMIS-10, EQ-5D) amongst the participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Rehazentrum Walenstadtberg	Walenstadtberg		Switzerland

Sponsors and Collaborators

Klinik Valens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Kruesi, Resident Physician, Doctoral Candidate, Klinik Valens

ClinicalTrials.gov Identifier:

NCT04025385

Other Study ID Numbers:

KLV-BA-2019-1

First Posted:

Jul 18, 2019

Last Update Posted:

Mar 3, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Mar 3, 2021