Hypoxia and Exercise in the Elderly

Elderly Persons Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196623
• Other study ID #: HA 7037/2-1
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2019

Study information

• Verified date: August 2017
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly Persons
• Hypoxia

Intervention

Other:
• Hypoxic exercise
Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions
• Normoxic Exercise
Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	German Diabetes Center

Country where clinical trial is conducted

Germany, 

Outcome

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