- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196623
Hypoxia and Exercise in the Elderly
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lower Saxony
-
Hannover, Lower Saxony, Germany, 30625
- Hannover Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypoxic Exercise
Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions
|
Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions
|
|
Sham Comparator: Normoxic exercise
Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions
|
Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At baseline and after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum oxygen uptake
Time Frame: At baseline and after 8 weeks
|
Maximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg
|
At baseline and after 8 weeks
|
|
Mitochondrial number
Time Frame: At baseline and after 8 weeks
|
Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.
|
At baseline and after 8 weeks
|
|
Fat and carbohydrate oxidation during exercise
Time Frame: At baseline and after 8 weeks
|
Fat and carbohydrate oxidation during exercise is assessed during an incremental exercise test by measurements of gas exchange and expressed as g/min
|
At baseline and after 8 weeks
|
|
Body fat and body fat free mass
Time Frame: At baseline and after 8 weeks
|
Measured via by air-displacement plethysmography (ADP) and expressed in kg
|
At baseline and after 8 weeks
|
|
Health related quality of life
Time Frame: At baseline and after 8 weeks
|
Assessed using the short form 36 (SF-36) questionnaires
|
At baseline and after 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven Haufe, Dr., Hannover Medical School
Publications and helpful links
General 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.
- Chobanyan-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HA 7037/2-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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