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Hypoxia and Exercise in the Elderly

Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02196623
Enrollment
29
Registered
2014-07-22
Start date
2015-06-30
Completion date
2019-01-31
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Persons

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.

Interventions

Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions

Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions

Sponsors

German Diabetes Center
CollaboratorOTHER
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivityAt baseline and after 8 weeksInsulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml

Secondary

MeasureTime frameDescription
Maximum oxygen uptakeAt baseline and after 8 weeksMaximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg
Mitochondrial numberAt baseline and after 8 weeksMitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.
Fat and carbohydrate oxidation during exerciseAt baseline and after 8 weeksFat and carbohydrate oxidation during exercise is assessed during an incremental exercise test by measurements of gas exchange and expressed as g/min
Body fat and body fat free massAt baseline and after 8 weeksMeasured via by air-displacement plethysmography (ADP) and expressed in kg
Health related quality of lifeAt baseline and after 8 weeksAssessed using the short form 36 (SF-36) questionnaires

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026