Hypoxia and Exercise in the Elderly

Not Applicable

Completed

• Conditions: Elderly Persons
• Interventions: Other: Normoxic Exercise; Other: Hypoxic exercise

• Registration Number: NCT02196623
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Study Start: 2015-06
• Status Verified: 2017-08
• Primary Completion: 2017-09
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normoxic exercise	Normoxic Exercise	Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions
Hypoxic Exercise	Hypoxic exercise	Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	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 Outcome Measures

Name	Time	Method
Maximum oxygen uptake	At baseline and after 8 weeks	Maximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg
Mitochondrial number	At baseline and after 8 weeks	Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.
Body fat and body fat free mass	At baseline and after 8 weeks	Measured via by air-displacement plethysmography (ADP) and expressed in kg
Fat and carbohydrate oxidation during exercise	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
Health related quality of life	At baseline and after 8 weeks	Assessed using the short form 36 (SF-36) questionnaires

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany