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Muscle WeaknessLISANCT02123641

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

A study testing Heavy resistance training and Moderate intensity training in people with Muscle Weakness and Muscle Loss, run by Bispebjerg Hospital at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 62 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Weakness, Muscle Loss, Sarcopenia
What is being tested?
Heavy resistance training and Moderate intensity training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
1 siteDenmark
Study dates
Apr 2014to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 62 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Independently living men and women
  • Between 62 and 70 years

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Bispebjerg Hospital

    Copenhagen NV, 2400

Other trials in Denmark

About this study

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).

Read more

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.

Read the 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.

Being tested
Heavy resistance training, Moderate intensity training, Control
Medical subject headings
Muscle Weakness, Muscular Atrophy, Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heavy resistance trainingOther

    Supervised heavy resistance training three times weekly for 52 weeks.

  • Moderate intensity trainingOther

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

  • ControlOther

    No training

Study groups in NCT02123641
Study groupRoleWhat they receive
Heavy resistance trainingActive comparatorHeavy resistance training of the lower and upper extremities three times weekly for 52 weeks.
Receives: Other: Heavy resistance training
Moderate intensity trainingExperimentalHome-based moderate intensity training of the lower and upper extremities three times weekly for 52 weeks.
Receives: Other: Moderate intensity training
ControlExperimentalNo training
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 1, 2, 4, 7, and 10 years follow up

Secondary outcomes (16)
  1. Change in quadriceps cross sectional area

    MRI scanning of thigh muscle composition

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  2. Change in maximal isometric quadriceps strength

    Unilateral maximal isometric quadriceps strength measured in the Good Strength device.

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  3. Change in 30 s chair stand performance

    Number of stand-ups from a chair in 30 seconds

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  4. Change in 400 m gait speed

    The time used for walking 400 m (20 m course)

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  5. 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.

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  6. Change in grip strength

    Isometric hand grip strength (Saehan dynamometer)

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  7. Change in perceived age

    Determination of perceived age from facial and whole-body photographs

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  8. 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.

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  9. Change in physical activity level

    Wearing a pedometer device (ActivPal) for 5 continuous days. Questionnaire: PASE (Physical Activity Scale for the Elderly).

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  10. Change in Exercise self-efficacy

    Questionnaire: Exercise Self-efficacy Scale.

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  11. Change in Health Related Quality of Life

    Questionnaire: SF36.

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  12. Changes in brain structure and function

    MRI scanning of the regional brain structure and function

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  13. Change in cognitive ability

    Questionnaire: IST 2000-R

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  14. Change in personality

    Questionnaire: NEO-FFI

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  15. Change in mental symptoms

    Questionnaire: SCL-90

    Measured: Baseline, 1, 2, 4, 7, and 10 years

  16. Adherence to training interventions

    Questionnaire developped specifically for the LISA study by the authores

    Measured: 2, 4, 7, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02123641
Sponsor's protocol ID
H-3-2014-017
Acronym
LISA
Status last verified
Sep 2017
First submitted
24 Apr 2014
Last updated
25 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Bloch-Ibenfeldt M, Demnitz N, Gates AT, Garde E, Siebner HR, Kjaer M, Boraxbekk CJ. No long-term benefits from resistance training on brain grey matter volumes in active older adults at retirement age. BMC Geriatr. 2025 Feb 21;25(1):120. doi: 10.1186/s12877-025-05778-z.

    PubMed 39984875
  • Bloch-Ibenfeldt M, Gates AT, Jorgensen NR, Linneberg A, Aadahl M, Kjaer M, Boraxbekk CJ. Heavy resistance training provides short-term benefits on bone formation in well-functioning older adults. Bone. 2025 Apr;193:117393. doi: 10.1016/j.bone.2025.117393. Epub 2025 Jan 18.

    PubMed 39832659
  • Bieler T, Magnusson SP, Kjaer M, Eriksen CS. Low adherence to prescribed time under tension in elastic band resistance training in older adults. An observational study. J Bodyw Mov Ther. 2024 Oct;40:1181-1188. doi: 10.1016/j.jbmt.2024.07.004. Epub 2024 Jul 10.

    PubMed 39593432
  • Bloch-Ibenfeldt M, Theil Gates A, Karlog K, Demnitz N, Kjaer M, Boraxbekk CJ. Heavy resistance training at retirement age induces 4-year lasting beneficial effects in muscle strength: a long-term follow-up of an RCT. BMJ Open Sport Exerc Med. 2024 Jun 18;10(2):e001899. doi: 10.1136/bmjsem-2024-001899. eCollection 2024.

    PubMed 38911477
  • 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.

    PubMed 32277977
  • 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.

    PubMed 30717697
  • 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.

    PubMed 30704412
  • 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.

    PubMed 27913559

Questions about this trial

What is this clinical trial studying?

A study testing Heavy resistance training and Moderate intensity training in people with Muscle Weakness and Muscle Loss, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in leg extensor power (time frame: Baseline, 1, 2, 4, 7, and 10 years follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02123641, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.

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