Bispebjerg Hospital
Copenhagen NV, 2400, Denmark
NCT Number: NCT02123641
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.
This study is active but is not currently recruiting participants.
62 year–70 year
All sexes
Interventional
Not applicable
Copenhagen NV, 2400, Denmark
Retirement has been recognized as a critical turning point in determining physical activity behaviours in old age. The literature gives a varying picture regarding change in physical activity level with work retirement but often a reduction in total physical activity has been reported. Retirement typically takes place at a time where the skeletal muscle mass, -strength and -power declines by 1-3% per year.
Interventions to promote physical activity in adults aged 55 to 70 years have been shown to be effective at 12 months but it is very unclear if the effect is maintained thereafter. Both exercise at home or at a center improves health and physical function - but home based programs appear to be superior to center based programs in terms of adherence to exercise especially in the long-term.
In older adults, strength training at 60% of 1RM has been shown to be sufficient for large effect on muscle function and muscle protein synthesis, and potentially lower loads (45-60% 1RM) have effect when adding more repetitions.
The overall objective of the study is to assess the long-term effects of 12 month of supervised high-intensity center based resistance training or "guided" moderate-intensity home-based resistance training relative to a non-exercising control group upon muscle power, -strength and -mass, physical function, physical activity level and health in older people around the time of retirement.
The hypotheses are:
450 participants recruited through advertisements in local newspapers will be included in this three-armed, single-blinded randomized trial. After baseline assessment they will be randomized to one year of 1) supervised, high-intensity progressive, resistance training conducted in machines three times weekly in a local fitness center 2) "guided" moderate-intensity home-based resistance training conducted with elastic bands and body weight three times weekly. "Guided" means that the participants are offered supervised resistance training once weekly in addition to home based resistance training 2 times weekly or 3) various social and cultural activities that do not require physical activity.
All participants complete a wide range of tests before and after the 12 months intervention period and the primary time point for outcome assessment will be at 12 month. The same "test battery" is conducted in the subsequent years (2, 4, 7, and 10 years later) as a follow-up.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supervised heavy resistance training three times weekly for 52 weeks.
Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.
No training
Time frame: 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).
Time frame: Baseline, 1, 2, 4, 7, and 10 years
MRI scanning of thigh muscle composition
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Unilateral maximal isometric quadriceps strength measured in the Good Strength device.
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Number of stand-ups from a chair in 30 seconds
Time frame: Baseline, 1, 2, 4, 7, and 10 years
The time used for walking 400 m (20 m course)
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Body composition (fat mass, lean mass and bone mass) evaluated by whole-body and regional (lumbar spine and femoral neck) dual energy x-ray absorptiometry (DXA)-scanning.
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Isometric hand grip strength (Saehan dynamometer)
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Determination of perceived age from facial and whole-body photographs
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Measuring 1) blood levels of inflammatory markers (CRP, TNFa, and IL-6) and HbA1c, plasma lipids. 2) Weight, abdominal circumference, blood pressure.
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Wearing a pedometer device (ActivPal) for 5 continuous days. Questionnaire: PASE (Physical Activity Scale for the Elderly).
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Questionnaire: Exercise Self-efficacy Scale.
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Questionnaire: SF36.
Time frame: Baseline, 1, 2, 4, 7, and 10 years
MRI scanning of the regional brain structure and function
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Questionnaire: IST 2000-R
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Questionnaire: NEO-FFI
Time frame: Baseline, 1, 2, 4, 7, and 10 years
Questionnaire: SCL-90
Time frame: 2, 4, 7, 10 years
Questionnaire developped specifically for the LISA study by the authores
Bispebjerg Hospital
Other
Acronym: LISA
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