RehabilitationNCT04025385
High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
A study testing High Intensity Interval Training in people with Rehabilitation and Post-Operative Condition, run by Klinik Valens at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Post-Operative Condition, Deconditioning After Acute Hospital
- What is being tested?
- High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jul 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- cardiopulmonal resilient
- able to sit on a ergometer
- knowledge of German written and spoken
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- High Intensity Interval Training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients will participate in regular training units |
| HIIT Group | Active comparator | Patients will participate in high intensity interval training Receives: Other: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Will there be a change in outcome of individuals vO2max?
Measurement of vO2max with spiroergometer at the beginning and end
Measured: 2 Weeks
Is a High intensity interval training feasible with elderly patients in rehabilitation?
Questionnaire (Clinic-intern questionnaire) amongst the involved personal
Measured: 1 Day
Secondary outcomes (1)
Will there be a change in subjective quality of life?
Questionnaires (PROMIS-10, EQ-5D) amongst the participants
Measured: 2.5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start30 Jul 2019
- Primary completion30 Sep 2020
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kruesi, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025385
- Sponsor's protocol ID
- KLV-BA-2019-1
- Status last verified
- Mar 2021
- First submitted
- 16 Jun 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study
- ClinicalTrials.gov ID
- NCT04025385
- Acronym / sponsor ID
- KLV-BA-2019-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients will participate in regular training units |
| HIIT Group | Active comparator | Other: High Intensity Interval TrainingPatients will participate in high intensity interval training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- cardiopulmonal resilient
- able to sit on a ergometer
- knowledge of German written and spoken
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingTraining for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits. | Other | HIIT Group |
Primary outcome
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
1 secondary outcome
Will there be a change in subjective quality of life?
Time frame: 2.5 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Rehabilitation and Post-Operative Condition, run by Klinik Valens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Will there be a change in outcome of individuals vO2max? (time frame: 2 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.