Hypoxia and Exercise in the Elderly

June 26, 2025 updated by: Hannover Medical School

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Sven Haufe, Dr., Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimated)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

August 1, 2017

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.

Clinical Trials on Elderly Persons

Clinical Trials on Hypoxic exercise

Subscribe