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

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ClinicalTrials.gov Identifier: NCT02123641
Recruitment Status : Active, not recruiting
First Posted : April 25, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
University of Copenhagen
Hvidovre University Hospital
Information provided by (Responsible Party):
Michael Kjaer, Bispebjerg Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Muscle Weakness Muscle Loss Sarcopenia Physical Activity Other: Heavy resistance training Other: Moderate intensity training Other: Control Not Applicable

Detailed Description:

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:

  1. Supervised high-intensity center based resistance training over one year results in the best improvement in muscle power and bodily function
  2. "Guided" moderate-intensity home-based resistance training will result in a more active lifestyle and thus in sustained elevated activity level after the 1-year intervention period. Thus in the long run (several years) "guided" moderate-intensity home-based resistance training has superior effects compared to supervised high-intensity center based resistance training upon functional ability, health and potentially also cognitive function.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
Study Start Date : April 2014
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: Heavy resistance training
Heavy resistance training of the lower and upper extremities three times weekly for 52 weeks.
Other: Heavy resistance training
Supervised heavy resistance training three times weekly for 52 weeks.

Experimental: Moderate intensity training
Home-based moderate intensity training of the lower and upper extremities three times weekly for 52 weeks.
Other: Moderate intensity training
Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.

Experimental: Control
No training
Other: Control
No training




Primary Outcome Measures :
  1. Change in leg extensor power [ 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).


Secondary Outcome Measures :
  1. Change in quadriceps cross sectional area [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    MRI scanning of thigh muscle composition

  2. Change in maximal isometric quadriceps strength [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Unilateral maximal isometric quadriceps strength measured in the Good Strength device.

  3. Change in 30 s chair stand performance [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Number of stand-ups from a chair in 30 seconds

  4. Change in 400 m gait speed [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    The time used for walking 400 m (20 m course)

  5. Change in whole body composition and bone mineral density as well as lumbar spine and femoral neck bone mineral density [ 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.

  6. Change in grip strength [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Isometric hand grip strength (Saehan dynamometer)

  7. Change in perceived age [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Determination of perceived age from facial and whole-body photographs

  8. Change in blood parameters and anthropometry [ 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.

  9. Change in physical activity level [ 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).

  10. Change in Exercise self-efficacy [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Questionnaire: Exercise Self-efficacy Scale.

  11. Change in Health Related Quality of Life [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Questionnaire: SF36.

  12. Changes in brain structure and function [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    MRI scanning of the regional brain structure and function

  13. Change in cognitive ability [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Questionnaire: IST 2000-R

  14. Change in personality [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Questionnaire: NEO-FFI

  15. Change in mental symptoms [ Time Frame: Baseline, 1, 2, 4, 7, and 10 years ]
    Questionnaire: SCL-90

  16. Adherence to training interventions [ Time Frame: 2, 4, 7, 10 years ]
    Questionnaire developped specifically for the LISA study by the authores



Information from the National Library of Medicine

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Ages Eligible for Study:   62 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123641


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
Hvidovre University Hospital
Investigators
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Principal Investigator: Kasper Dideriksen, PhD stud Bispebjerg Hospital
Principal Investigator: Anne Gylling, PhD stud Bispebjerg Hospital
Principal Investigator: Christian Eriksen, PhD stud Bispebjerg Hospital
Principal Investigator: Michael Kjaer, MD, Proff Bispebjerg Hospital
Principal Investigator: Andreas Ziegler, PhD stud Bispebjerg Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Kjaer, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02123641     History of Changes
Other Study ID Numbers: H-3-2014-017
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Muscle Weakness
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes