Elderly PersonsNCT02196623
Hypoxia and Exercise in the Elderly
A study testing Hypoxic exercise and Normoxic Exercise in people with Elderly Persons, run by Hannover Medical School at 1 site in Germany.
Trial summary
Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Persons
- What is being tested?
- Hypoxic exercise and Normoxic Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jan 2019
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 to 75 years of age
- body mass index: 20 - 35 kg/m2
- weight stable during last 6 months before screening (weight change < 2% body weight)
- HOMA-index of insulin resistance ≥ 2 to 4 units
Who cannot join
- more than 1 hour of scheduled exercise training per week
- known diagnosis of type 2 diabetes or measured HbA1c > 6,5%
- known drug or alcohol abuse
- any contraindication to perform exercise training
- acute or chronic infections
- increased bleeding risk by history, INR > 1,3, use of anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction
Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic disease and frailty, which limits physical mobility as well as quality of life, share common cellular mechanisms.
The investigators will test the hypothesis that a combination of normobaric hypoxia and exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle dysfunction and the investigators will address the molecular mechanisms. In a randomized clinical study, the investigators will compare normoxic and hypoxic training conditions in elderly subjects. Outcome measures will focus on whole body insulin sensitivity and mitochondrial responses in skeletal muscle before and after the 8-week training intervention.
- Conditions
- Elderly Persons
- Being tested
- Hypoxic exercise, Normoxic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic exerciseOther
Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions
Normoxic ExerciseOther
Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic Exercise | Experimental | Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions Receives: Other: Hypoxic exercise |
| Normoxic exercise | Sham comparator | Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions Receives: Other: Normoxic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml
Measured: At baseline and after 8 weeks
Secondary outcomes (5)
Maximum oxygen uptake
Maximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg
Measured: At baseline and after 8 weeks
Mitochondrial number
Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.
Measured: At baseline and after 8 weeks
Fat and carbohydrate oxidation during exercise
Fat and carbohydrate oxidation during exercise is assessed during an incremental exercise test by measurements of gas exchange and expressed as g/min
Measured: At baseline and after 8 weeks
Body fat and body fat free mass
Measured via by air-displacement plethysmography (ADP) and expressed in kg
Measured: At baseline and after 8 weeks
Health related quality of life
Assessed using the short form 36 (SF-36) questionnaires
Measured: At baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elderly PersonsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Diabetes Center
- Responsible party
- Sponsor
- Investigators
- Sven Haufe, Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196623
- Sponsor's protocol ID
- HA 7037/2-1
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2014
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hein M, Chobanyan-Jurgens K, Tegtbur U, Engeli S, Jordan J, Haufe S. Effect of normobaric hypoxic exercise on blood pressure in old individuals. Eur J Appl Physiol. 2021 Mar;121(3):817-825. doi: 10.1007/s00421-020-04572-6. Epub 2020 Dec 23.
PubMed 33355713Chobanyan-Jurgens K, Scheibe RJ, Potthast AB, Hein M, Smith A, Freund R, Tegtbur U, Das AM, Engeli S, Jordan J, Haufe S. Influences of Hypoxia Exercise on Whole-Body Insulin Sensitivity and Oxidative Metabolism in Older Individuals. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5238-5248. doi: 10.1210/jc.2019-00411.
PubMed 30942862
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction
- ClinicalTrials.gov ID
- NCT02196623
- Acronym / sponsor ID
- HA 7037/2-1
- Conditions
- Elderly Persons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Diabetes Center
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
Ageing is the primary risk factor for most chronic diseases including type 2 diabetes mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic disease and frailty, which limits physical mobility as well as quality of life, share common cellular mechanisms.
The investigators will test the hypothesis that a combination of normobaric hypoxia and exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle dysfunction and the investigators will address the molecular mechanisms. In a randomized clinical study, the investigators will compare normoxic and hypoxic training conditions in elderly subjects. Outcome measures will focus on whole body insulin sensitivity and mitochondrial responses in skeletal muscle before and after the 8-week training intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxic Exercise | Experimental | Other: Hypoxic exerciseSupervised, progressive aerobic exercise for 8 weeks under hypoxic conditions |
| Normoxic exercise | Sham comparator | Other: Normoxic ExerciseSupervised, progressive aerobic exercise for 8 weeks under normoxic conditions |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55 to 75 years of age
- body mass index: 20 - 35 kg/m2
- weight stable during last 6 months before screening (weight change < 2% body weight)
- HOMA-index of insulin resistance ≥ 2 to 4 units
Key exclusion criteria (6 listed)
- more than 1 hour of scheduled exercise training per week
- known diagnosis of type 2 diabetes or measured HbA1c > 6,5%
- known drug or alcohol abuse
- any contraindication to perform exercise training
- acute or chronic infections
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 |
|---|---|---|
| Hypoxic exerciseSupervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions | Other | Hypoxic Exercise |
| Normoxic ExerciseSupervised, progressive aerobic exercise program for 8 weeks under normoxic conditions | Other | Normoxic exercise |
Primary outcome
Insulin sensitivity
Time frame: At baseline and after 8 weeks
Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml
5 secondary outcomes
Maximum oxygen uptake
Time frame: At baseline and after 8 weeks
Mitochondrial number
Time frame: At baseline and after 8 weeks
Fat and carbohydrate oxidation during exercise
Time frame: At baseline and after 8 weeks
Body fat and body fat free mass
Time frame: At baseline and after 8 weeks
Health related quality of life
Time frame: At baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Results publication: PubMed 33355713Hein M, Chobanyan-Jurgens K, Tegtbur U, Engeli S, Jordan J, Haufe S. Effect of normobaric hypoxic exercise on blood pressure in old individuals. Eur J Appl Physiol. 2021 Mar;121(3):817-825. doi: 10.1007/s00421-020-04572-6. Epub 2020 Dec 23.
- Results publication: PubMed 30942862Chobanyan-Jurgens K, Scheibe RJ, Potthast AB, Hein M, Smith A, Freund R, Tegtbur U, Das AM, Engeli S, Jordan J, Haufe S. Influences of Hypoxia Exercise on Whole-Body Insulin Sensitivity and Oxidative Metabolism in Older Individuals. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5238-5248. doi: 10.1210/jc.2019-00411.
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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.
Sven Haufe, Dr. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic exercise and Normoxic Exercise in people with Elderly Persons, run by Hannover Medical School at 1 site in Germany.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jun 2025. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity (time frame: At baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196623, which also lists 2 linked publications.
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 29 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.