Hypoxia and Exercise in the Elderly

NCT ID: NCT02196623

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elderly Persons

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hypoxic Exercise

Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions

Group Type EXPERIMENTAL

Hypoxic exercise

Intervention Type OTHER

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

Normoxic exercise

Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions

Group Type SHAM_COMPARATOR

Normoxic Exercise

Intervention Type OTHER

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

Interventions

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Hypoxic exercise

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

Intervention Type OTHER

Normoxic Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Diabetes Center

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven Haufe, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 33355713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30942862 (View on PubMed)

Other Identifiers

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HA 7037/2-1

Identifier Type: -

Identifier Source: org_study_id

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