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

Primary Purpose

Muscle Weakness, Muscle Loss, Sarcopenia

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Heavy resistance training
Moderate intensity training
Control
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Weakness

Eligibility Criteria

62 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Heavy resistance training

Moderate intensity training

Control

Arm Description

Heavy resistance training of the lower and upper extremities three times weekly for 52 weeks.

Home-based moderate intensity training of the lower and upper extremities three times weekly for 52 weeks.

No training

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in quadriceps cross sectional area
MRI scanning of thigh muscle composition
Change in maximal isometric quadriceps strength
Unilateral maximal isometric quadriceps strength measured in the Good Strength device.
Change in 30 s chair stand performance
Number of stand-ups from a chair in 30 seconds
Change in 400 m gait speed
The time used for walking 400 m (20 m course)
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.
Change in grip strength
Isometric hand grip strength (Saehan dynamometer)
Change in perceived age
Determination of perceived age from facial and whole-body photographs
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.
Change in physical activity level
Wearing a pedometer device (ActivPal) for 5 continuous days. Questionnaire: PASE (Physical Activity Scale for the Elderly).
Change in Exercise self-efficacy
Questionnaire: Exercise Self-efficacy Scale.
Change in Health Related Quality of Life
Questionnaire: SF36.
Changes in brain structure and function
MRI scanning of the regional brain structure and function
Change in cognitive ability
Questionnaire: IST 2000-R
Change in personality
Questionnaire: NEO-FFI
Change in mental symptoms
Questionnaire: SCL-90
Adherence to training interventions
Questionnaire developped specifically for the LISA study by the authores

Full Information

First Posted
April 24, 2014
Last Updated
September 22, 2017
Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02123641
Brief Title
Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
Acronym
LISA
Official Title
Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Supervised high-intensity center based resistance training over one year results in the best improvement in muscle power and bodily function "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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Muscle Loss, Sarcopenia, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heavy resistance training
Arm Type
Active Comparator
Arm Description
Heavy resistance training of the lower and upper extremities three times weekly for 52 weeks.
Arm Title
Moderate intensity training
Arm Type
Experimental
Arm Description
Home-based moderate intensity training of the lower and upper extremities three times weekly for 52 weeks.
Arm Title
Control
Arm Type
Experimental
Arm Description
No training
Intervention Type
Other
Intervention Name(s)
Heavy resistance training
Intervention Description
Supervised heavy resistance training three times weekly for 52 weeks.
Intervention Type
Other
Intervention Name(s)
Moderate intensity training
Intervention Description
Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No training
Primary Outcome Measure Information:
Title
Change in leg extensor power
Description
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 follow up
Secondary Outcome Measure Information:
Title
Change in quadriceps cross sectional area
Description
MRI scanning of thigh muscle composition
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in maximal isometric quadriceps strength
Description
Unilateral maximal isometric quadriceps strength measured in the Good Strength device.
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in 30 s chair stand performance
Description
Number of stand-ups from a chair in 30 seconds
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in 400 m gait speed
Description
The time used for walking 400 m (20 m course)
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in whole body composition and bone mineral density as well as lumbar spine and femoral neck bone mineral density
Description
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
Title
Change in grip strength
Description
Isometric hand grip strength (Saehan dynamometer)
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in perceived age
Description
Determination of perceived age from facial and whole-body photographs
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in blood parameters and anthropometry
Description
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
Title
Change in physical activity level
Description
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
Title
Change in Exercise self-efficacy
Description
Questionnaire: Exercise Self-efficacy Scale.
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in Health Related Quality of Life
Description
Questionnaire: SF36.
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Changes in brain structure and function
Description
MRI scanning of the regional brain structure and function
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in cognitive ability
Description
Questionnaire: IST 2000-R
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in personality
Description
Questionnaire: NEO-FFI
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Change in mental symptoms
Description
Questionnaire: SCL-90
Time Frame
Baseline, 1, 2, 4, 7, and 10 years
Title
Adherence to training interventions
Description
Questionnaire developped specifically for the LISA study by the authores
Time Frame
2, 4, 7, 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
62 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasper Dideriksen, PhD stud
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Gylling, PhD stud
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Eriksen, PhD stud
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, MD, Proff
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Ziegler, PhD stud
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32277977
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.
Results Reference
derived
PubMed Identifier
30717697
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.
Results Reference
derived
PubMed Identifier
30704412
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.
Results Reference
derived
PubMed Identifier
27913559
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.
Results Reference
derived

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

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