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

NCT02123641 | Active Not Recruiting DMC

• 1 other identifier: H-3-2014-017
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; Muscle Loss; Sarcopenia; Physical Activity

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (16)

• Change in quadriceps cross sectional area

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

• Change in maximal isometric quadriceps strength

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

• Change in 30 s chair stand performance

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

• Change in 400 m gait speed

  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

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

Study Arms (3)

Heavy resistance training

ACTIVE COMPARATOR

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

Other: Heavy resistance training

Moderate intensity training

EXPERIMENTAL

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

Other: Moderate intensity training

Control

EXPERIMENTAL

No training

Other: Control

Interventions

Heavy resistance training OTHER

Supervised heavy resistance training three times weekly for 52 weeks.

Heavy resistance training

Moderate intensity training OTHER

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

Moderate intensity training

Control OTHER

No training

Control

Eligibility Criteria

• Age: 62 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Related Publications (7)

• 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.

  PMID: 39984875 DERIVED

• 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.

  PMID: 39832659 DERIVED

• 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.

  PMID: 38911477 DERIVED

• 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.

  PMID: 32277977 DERIVED

• 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.

  PMID: 30717697 DERIVED

• 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.

  PMID: 30704412 DERIVED

• 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.

  PMID: 27913559 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Muscular Atrophy; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

DK (1)