Skip to main content
OpenTrials
Completed

NCT Number: NCT02196623

Hypoxia and Exercise in the Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Elderly Persons

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxic exercise

Other

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

Normoxic Exercise

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Mitochondrial number

    Time frame: At baseline and after 8 weeks

    Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.

  3. 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

  4. 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

  5. Health related quality of life

    Time frame: At baseline and after 8 weeks

    Assessed using the short form 36 (SF-36) questionnaires

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • German Diabetes Center

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 22, 2014
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.