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

Physical Activity Clinical Trial

— LISA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02123641
• Other study ID #: H-3-2014-017
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2014
• Last updated: September 22, 2017
• Start date: April 2014
• Est. completion date: June 2028

Study information

• Verified date: September 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 451
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 62 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Loss
• Muscle Weakness
• Paresis
• Physical Activity
• Sarcopenia

Intervention

Other:
• Heavy resistance training
Supervised heavy resistance training three times weekly for 52 weeks.
• Moderate intensity training
Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.
• Control
No training

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hvidovre University Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in quadriceps cross sectional area	MRI scanning of thigh muscle composition	Baseline, 1, 2, 4, 7, and 10 years
Secondary	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
Secondary	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
Secondary	Change in 400 m gait speed	The time used for walking 400 m (20 m course)	Baseline, 1, 2, 4, 7, and 10 years
Secondary	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
Secondary	Change in grip strength	Isometric hand grip strength (Saehan dynamometer)	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Change in perceived age	Determination of perceived age from facial and whole-body photographs	Baseline, 1, 2, 4, 7, and 10 years
Secondary	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
Secondary	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
Secondary	Change in Exercise self-efficacy	Questionnaire: Exercise Self-efficacy Scale.	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Change in Health Related Quality of Life	Questionnaire: SF36.	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Changes in brain structure and function	MRI scanning of the regional brain structure and function	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Change in cognitive ability	Questionnaire: IST 2000-R	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Change in personality	Questionnaire: NEO-FFI	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Change in mental symptoms	Questionnaire: SCL-90	Baseline, 1, 2, 4, 7, and 10 years
Secondary	Adherence to training interventions	Questionnaire developped specifically for the LISA study by the authores	2, 4, 7, 10 years