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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Muscle Weakness; Sarcopenia; Muscle Loss
• Intervention / Treatment: Other: Heavy resistance training; Other: Moderate intensity training; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 451
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen NV, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 62 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in leg extensor power	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).	Baseline, 1, 2, 4, 7, and 10 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quadriceps cross sectional area	MRI scanning of thigh muscle composition	Baseline, 1, 2, 4, 7, and 10 years
Change in maximal isometric quadriceps strength	Unilateral maximal isometric quadriceps strength measured in the Good Strength device.	Baseline, 1, 2, 4, 7, and 10 years
Change in 30 s chair stand performance	Number of stand-ups from a chair in 30 seconds	Baseline, 1, 2, 4, 7, and 10 years
Change in 400 m gait speed	The time used for walking 400 m (20 m course)	Baseline, 1, 2, 4, 7, and 10 years
Change in whole body composition and bone mineral density as well as lumbar spine and femoral neck bone mineral density	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.	Baseline, 1, 2, 4, 7, and 10 years
Change in grip strength	Isometric hand grip strength (Saehan dynamometer)	Baseline, 1, 2, 4, 7, and 10 years
Change in perceived age	Determination of perceived age from facial and whole-body photographs	Baseline, 1, 2, 4, 7, and 10 years
Change in blood parameters and anthropometry	Measuring 1) blood levels of inflammatory markers (CRP, TNFa, and IL-6) and HbA1c, plasma lipids. 2) Weight, abdominal circumference, blood pressure.	Baseline, 1, 2, 4, 7, and 10 years
Change in physical activity level	Wearing a pedometer device (ActivPal) for 5 continuous days. Questionnaire: PASE (Physical Activity Scale for the Elderly).	Baseline, 1, 2, 4, 7, and 10 years
Change in Exercise self-efficacy	Questionnaire: Exercise Self-efficacy Scale.	Baseline, 1, 2, 4, 7, and 10 years
Change in Health Related Quality of Life	Questionnaire: SF36.	Baseline, 1, 2, 4, 7, and 10 years
Changes in brain structure and function	MRI scanning of the regional brain structure and function	Baseline, 1, 2, 4, 7, and 10 years
Change in cognitive ability	Questionnaire: IST 2000-R	Baseline, 1, 2, 4, 7, and 10 years
Change in personality	Questionnaire: NEO-FFI	Baseline, 1, 2, 4, 7, and 10 years
Change in mental symptoms	Questionnaire: SCL-90	Baseline, 1, 2, 4, 7, and 10 years
Adherence to training interventions	Questionnaire developped specifically for the LISA study by the authores	2, 4, 7, 10 years

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: University of Copenhagen; Hvidovre University Hospital
• Investigators: 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 and helpful links

General Publications

• Gylling AT, Eriksen CS, Garde E, Wimmelmann CL, Reislev NL, Bieler T, Ziegler AK, Andersen KW, Bauer C, Dideriksen K, Baekgaard M, Mertz KH, Bayer ML, Bloch-Ibenfeldt M, Boraxbekk CJ, Siebner HR, Mortensen EL, Kjaer M. The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults. Exp Gerontol. 2020 Jul 15;136:110939. doi: 10.1016/j.exger.2020.110939. Epub 2020 Apr 8.
• Modig K, Talback M, Ziegler L, Ahlbom A. Temporal trends in incidence, recurrence and prevalence of stroke in an era of ageing populations, a longitudinal study of the total Swedish population. BMC Geriatr. 2019 Feb 4;19(1):31. doi: 10.1186/s12877-019-1050-1.
• Eriksen CS, Svensson RB, Gylling AT, Couppe C, Magnusson SP, Kjaer M. Load magnitude affects patellar tendon mechanical properties but not collagen or collagen cross-linking after long-term strength training in older adults. BMC Geriatr. 2019 Jan 31;19(1):30. doi: 10.1186/s12877-019-1043-0.
• Eriksen CS, Garde E, Reislev NL, Wimmelmann CL, Bieler T, Ziegler AK, Gylling AT, Dideriksen KJ, Siebner HR, Mortensen EL, Kjaer M. Physical activity as intervention for age-related loss of muscle mass and function: protocol for a randomised controlled trial (the LISA study). BMJ Open. 2016 Dec 2;6(12):e012951. doi: 10.1136/bmjopen-2016-012951.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): June 1, 2028
• Study Completion (Anticipated): June 1, 2028

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscle Weakness; Sarcopenia
• Other Study ID Numbers: H-3-2014-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED