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Active, not recruiting Not applicable

Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function

NCT02123641 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2014-04
Last updated
2017-09-25

Condition(s) studied

Muscle WeaknessMuscle LossSarcopeniaPhysical Activity

Investigational drug(s) / intervention(s)

Heavy resistance trainingModerate intensity trainingControl

Heavy resistance training: Supervised heavy resistance training three times weekly for 52 weeks.

Moderate intensity training: Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.

Control: No training

Study summary

A minimum of 450 healthy individuals (62-70 years old) will be recruited.

Each individual will be randomized into one of three groups stratified according to gender (M/F), BMI (≤28/\>28), and 30 sec chair stand (≤11/\>11). The three groups are Heavy resistance training (n=150), moderate intensity training (n=150), and control (n=150, no training).

Assessments will be performed at baseline, after 12 months of intervention. Furthermore, follow up will be performed after 2,4,7, and 10 years.

The primary outcome is change in leg extensor power after the intervention and during follow up.

The primary hypothesis is that by applying the intention-to-treat analysis, the moderate intensity training group will increase leg extensor power just as much as the heavy resistance training group. The two training groups will increase muscle power more than the control group.

Eligibility

Sex
ALL
Min age
62 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Independently living men and women * Between 62 and 70 years Exclusion Criteria: * Subjects dependent on help/nursing etc. * Severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, non-treated hyper/hypothyroidism, dementia, active cancer. * Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens. * Implanted magnetic devices incompatible with MRi-scanning. * \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.

Primary outcome measure(s)

  • Change in leg extensor power — Baseline, 1, 2, 4, 7, and 10 years follow up
    Unilateral leg extension power measured in the Leg Extensor Power Rig device (Nottingham). The primary time interval for assessment of the primary outcome measure is from baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing the three groups before/after the intervention and during follow up (1,2,4,7, and 10 years).

Trial sites (1)

FacilityCityRegionStatus
Bispebjerg Hospital Copenhagen NV Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02123641 on ClinicalTrials.gov ↗ ← All trials in Denmark