Clinical trial NCT06718023: Diverse Training Programs and Sarcopenia in Postmenopausal Women
Official title: Effect of Diverse Training Programs on Prevention of Sarcopenia in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
postmenopausal women
Nordic walking
Strength training
Bungy Pump Exercises
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study explored preventive measures for sarcopenia in apparently healthy postmenopausal women. The investigators implemented a short Nordic walking intervention, Bungy Pumo exercises and strength training, and conducted a 3-month training program as an intervention method. The subjects divided into the NW (Nordic walking) test group, the ST (Strength Training) test group, BP (Bungy Pump exercises) test group and the control group, which engaged in regular daily activities without any additional physical exercise. The collected experimental data then processed and analyzed to objectively assess the benefits and limitations of different interventions.

Detailed description: The tests were conducted twice (before and after the training period). Each test lasted two days and will be preceded by a 7-day measurement of physical activity using sport testers. On the first day, blood tests, microbiota, body composition and a preliminary analysis of diet diaries were performed. On the second day, physical fitness tests were carried out in the Physical Exercise Laboratory of the AWFiS in Gdańsk. Biological material (blood serum and feces) was frozen for testing by the project contractors in the Laboratory of Genetics in Sports of the AWFiS. The subjects were required to keep a diet diary in which they recorded meals during the 3 days preceding the blood and intestinal microbiota test.

Eligibility criteria: Inclusion Criteria:

Postmenopausal women over 60 years old (i.e. more than 12 months since their last menstrual cycle).

There were no contraindications to exercise after case reports and initial diagnosis.

Informed consent must be signed, agreeing to participate in research and physical exercise programs.

Exclusion Criteria:

Uncontrolled high blood pressure. Coronary artery disease. Rheumatoid arthritis. Type 2 diabetes. Respiratory diseases and lung diseases. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.

Primary outcomes:
measure: Skeletal muscle index
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Gait Speed
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Hand Strength
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal Muscle Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: Right Arm Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Left Arm Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Trunk Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Right Leg Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Left Leg Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Skeletal Lean Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: PEAK AWY
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: PEAK TWD
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Arm Circumference
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: ChairStand
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: ArmCurl
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: TUG
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: TandemBalance
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Muscle Strength Indices
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Myostatin
timeFrame: From enrollment to the end of treatment at 3 months
measure: Irisin
timeFrame: From enrollment to the end of treatment at 3 months.
measure: BDNF
timeFrame: From enrollment to the end of treatment at 3 months.
Other outcomes:
measure: Creatinine
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Creatine kinase
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Body Fat Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Fat-Free Mass
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: BMI
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Microbiome analysis
timeFrame: From enrollment to the end of treatment at 3 months
measure: CRP
timeFrame: From enrollment to the end of treatment at 3 months
measure: IL-6
timeFrame: From enrollment to the end of treatment at 3 months.
measure: TNF-α
timeFrame: From enrollment to the end of treatment at 3 months.
measure: Nutrition assessment
timeFrame: From enrollment to the end of treatment at 3 months
Locations:
city: Gdansk
country: Poland
facility: Gdansk University of Physical Education and Sport
Study officials:
affiliation: AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTU
name: Zbigniew Ossowski Professor, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ossowski ZM, Skrobot W, Aschenbrenner P, Cesnaitiene VJ, Smaruj M. Effects of short-term Nordic walking training on sarcopenia-related parameters in women with low bone mass: a preliminary study. Clin Interv Aging. 2016 Nov 30;11:1763-1771. doi: 10.2147/CIA.S118995. eCollection 2016.
citation: Li T, Yin D, Shi R. Gut-muscle axis mechanism of exercise prevention of sarcopenia. Front Nutr. 2024 Aug 16;11:1418778. doi: 10.3389/fnut.2024.1418778. eCollection 2024.
citation: Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
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citation: Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet. 2009 Oct 3;374(9696):1196-208. doi: 10.1016/S0140-6736(09)61460-4.
citation: Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.