Clinical trial NCT02123641: Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
Official title: Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Weakness
Muscle Loss
Sarcopenia
Physical Activity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Hvidovre University Hospital
First posted: 2014-04-25
Enrollment: 451
Sex: ALL
Minimum age (years): 62
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in leg extensor power
timeFrame: Baseline, 1, 2, 4, 7, and 10 years follow up
Secondary outcomes:
measure: Change in quadriceps cross sectional area
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in maximal isometric quadriceps strength
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in 30 s chair stand performance
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in 400 m gait speed
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in whole body composition and bone mineral density as well as lumbar spine and femoral neck bone mineral density
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in grip strength
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in perceived age
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in blood parameters and anthropometry
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in physical activity level
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in Exercise self-efficacy
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in Health Related Quality of Life
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Changes in brain structure and function
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in cognitive ability
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in personality
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Change in mental symptoms
timeFrame: Baseline, 1, 2, 4, 7, and 10 years
measure: Adherence to training interventions
timeFrame: 2, 4, 7, 10 years
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Kasper Dideriksen, PhD stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Anne Gylling, PhD stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Christian Eriksen, PhD stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Michael Kjaer, MD, Proff
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Andreas Ziegler, PhD stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.