Clinical trial NCT02196623: Hypoxia and Exercise in the Elderly
Official title: Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Persons
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: German Diabetes Center
First posted: 2014-07-22
Enrollment: 29
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: At baseline and after 8 weeks
Secondary outcomes:
measure: Maximum oxygen uptake
timeFrame: At baseline and after 8 weeks
measure: Mitochondrial number
timeFrame: At baseline and after 8 weeks
measure: Fat and carbohydrate oxidation during exercise
timeFrame: At baseline and after 8 weeks
measure: Body fat and body fat free mass
timeFrame: At baseline and after 8 weeks
measure: Health related quality of life
timeFrame: At baseline and after 8 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Sven Haufe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.