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AzTrials

SarcopeniaPA&SPNCT06718023

Diverse Training Programs and Sarcopenia in Postmenopausal Women

A study testing Nordic walking, Strength training and Bungy Pump Exercises in people with Sarcopenia, run by Gdansk University of Physical Education and Sport at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
Nordic walking, Strength training and Bungy Pump Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 sitePoland
Study dates
1 Jun 2023to 15 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

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 60 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Gdansk University of Physical Education and Sport

    Gdansk, 80-336

Other trials in Poland

About this study

Official title: Effect of Diverse Training Programs on Prevention of Sarcopenia in Postmenopausal Women

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.

Read the 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.

Conditions
Sarcopenia
Being tested
Nordic walking, Strength training, Bungy Pump Exercises
Keywords
sarcopenia, postmenopausal women, Nordic walking, Strength training, Bungy Pump Exercises
Medical subject headings
Sarcopenia

What participants receive

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

  • Nordic walkingBehavioural

    NW training sessions are conducted by a certified NW instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. Participants used professional Nordic Pole.

  • Strength trainingBehavioural

    Strength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest.

  • Bungy Pump ExercisesBehavioural

    Buny Pump training sessions are conducted by a certified BP instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, , a total of 12 weeks. Participants used professional Bungy Pump Pole.

Study groups in NCT06718023
Study groupRoleWhat they receive
Nordic walkingExperimentalTraining is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. The primary focus is on utilizing a specialized pole for engaging in cross-country walking. This regimen entails approximately 10 minutes of warm-up exercises, followed by around 40 minutes of brisk walking, and concluding with a period of relaxation stretching lasting between 5 to 8 minutes.
Receives: Behavioral: Nordic walking
Daily lifeNo interventionThe individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion.
Strength trainingExperimentalStrength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest.
Receives: Behavioral: Strength training
Bungy Pump ExercisesExperimentalThe training lasts approximately 60 minutes each time, 3 times a week, for a period of 12 weeks. The main emphasis is placed on the use of a specialist Bungy Pump pole. Bungy Pump training allows participants to combine aerobic and strength training. Bungy Pump poles contain a built-in shock absorber (RSA) in the form of an elastic band. The additional resistance generated by the stretched band increases the overall intensity of the exercise and increases calorie consumption. The program classes will include approximately 10 minutes of warm-up exercises, followed by approximately 40 minutes of brisk walking, and at the end a period of relaxation stretching lasting from 5 to 8 minutes.
Receives: Behavioral: Bungy Pump Exercises

What is being measured

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

  1. Skeletal muscle index

    SMI in InBody is calculated as follows: SMI= sum of segmental muscle mass (two arms and two legs) ÷ height 2

    Measured: From enrollment to the end of treatment at 2 weeks

  2. Gait Speed

    In order to harmonize the pace measurement method, the 2019 Asian Sarcopenia Working Group recommends the time it takes to walk 6 meters at a normal pace from moving as a measure of average pace. The test is carried out in an inspection room that is more than 8 meters long. Crutches that participants normally use can also be used. The start and end of the 6-meter distance are clearly marked. Subjects stand with their toes touching the starting line, and after being instructed to move forward at their usual speed, subjects start walking, inspectors start timing, and when subjects fully cross the 6-meter mark with one foot, inspectors stop timing. The test is performed twice, recording the shortest time (in seconds) required to complete each distance. The smaller the value, the faster the walking speed, the better the physical ability.

    Measured: From enrollment to the end of treatment at 2 weeks

  3. Hand Strength

    HS was measured to estimate muscle strength and was performed with a hand dynamometer (SAEHAN Digital Hand Dynamometer, SAEHAN, Changwon, Korea). During the HS test, participants had to hold the dynamometer in their hand with the arm stretched parallel to the body while being instructed to stand upright. This measure was performed three times on the dominant hand with a rest interval of 1 min between measurements; finally, the best performance was used as the maximum peak (PK) of HS (in kg). The statistical analysis also included mean peak (mean PK).The higher the grip strength value, the greater the muscle strength, the better the physical ability.

    Measured: From enrollment to the end of treatment at 2 weeks

  4. Skeletal Muscle Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes.The higher the number, the more muscle the human body has.The ideal skeletal muscle content for men is 47% of standard body weight and 42% of standard body weight for women. A 10% move up or down is considered normal.

    Measured: From enrollment to the end of treatment at 2 weeks

Secondary outcomes (17)
  1. Right Arm Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher number indicates more muscle in the right arm.

    Measured: From enrollment to the end of treatment at 2 weeks

  2. Left Arm Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher number indicates more muscle in the left arm.

    Measured: From enrollment to the end of treatment at 2 weeks

  3. Trunk Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher number indicates more muscle in the trunk.

    Measured: From enrollment to the end of treatment at 2 weeks

  4. Right Leg Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher number indicates more muscle in the right leg.

    Measured: From enrollment to the end of treatment at 2 weeks

  5. Left Leg Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher number indicates more muscle in the left leg.

    Measured: From enrollment to the end of treatment at 2 weeks

  6. Skeletal Lean Mass

    Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The calculation method of SLM is different from that of SMM. The SLM in InBody report paper is the sum of protein, body water, and extracosseous inorganic salts. The ideal SLM for men is 80% of standard body weight and 72% of standard body weight for women. A 10% move up or down is considered normal.

    Measured: From enrollment to the end of treatment at 2 weeks

  7. PEAK AWY

    Peak knee extension muscle strength.Using Biodex System 4 Pro™ dynamometers (Biodex Medical Systems, Inc.) Data collection using Compaq Desk Pro personal computers and Biodex software, using the Biodex standard protocol. After a standardized warm-up, the subject is positioned in the equipment as required by the manufacturer's manual (sitting position, arms hanging down along the body, hands holding the outside handle, torso, buttocks and subject thighs secured by straps, knee flexion to 90°). The test uses the scheme reported by Symons et al., with some modifications. The isometric muscle strength test was performed using three maximum contractions, each lasting 5 seconds with an interval of 30 seconds. Adjust the seat position according to the length of each subject's legs. Data were analyzed using the results of the dominant lower limbs.

    The greater the value of this index, the stronger the isometric contraction force of the knee extensor muscle.

    Measured: From enrollment to the end of treatment at 2 weeks

  8. PEAK TWD

    Peak knee flexor strength. Using Biodex System 4 Pro™ dynamometers (Biodex Medical Systems, Inc.) Data collection using Compaq Desk Pro personal computers and Biodex software, using the Biodex standard protocol. After a standardized warm-up, the subject is positioned in the equipment as required by the manufacturer's manual (sitting position, arms hanging down along the body, hands holding the outside handle, torso, buttocks and subject thighs secured by straps, knee flexion to 90°). The test uses the scheme reported by Symons et al., with some modifications. The isometric muscle strength test was performed using three maximum contractions, each lasting 5 seconds with an interval of 30 seconds. Adjust the seat position according to the length of each subject's legs. Data were analyzed using the results of the dominant lower limbs.

    The higher the value of this index, the stronger the isometric contraction force of knee flexor muscle.

    Measured: From enrollment to the end of treatment at 2 weeks

  9. Arm Circumference

    A tape measure was used to directly measure the circumference of the left and right upper arms of the participants. The larger the value of the index, the larger the arm circumference, but it can only be used as a reference indicator and cannot specifically evaluate the physical function

    Measured: From enrollment to the end of treatment at 2 weeks

  10. ChairStand

    The participants stood up as fast as they could on a chair of suitable height for 30 seconds. The greater the value of this test, the more times it is proved to be completed, and the lower limb muscle strength can be indirectly evaluated.

    Measured: From enrollment to the end of treatment at 2 weeks

  11. ArmCurl

    Participants were asked to sit in a chair holding a 2KG weight with one arm and complete the maximum number of arm curls within 30 seconds. The greater the number of bends, the better the upper body strength may prove.

    Measured: From enrollment to the end of treatment at 2 weeks

  12. TUG

    Time up and go.The TUG test measures the time(s) required for a subject to rise from a chair, walk 3 m, turn around, walk back to the chair, and sit down. It has been shown to be a predictor of sarcopenia in hospitalized patients with a mean age of 70.4±7.7 years.The smaller the value, the shorter the completion time, and the better the physical function.

    Measured: From enrollment to the end of treatment at 2 weeks

  13. TandemBalance

    Participants used the "toe" stick to the "heel" in a straight line walking way, with the fastest speed to complete 2 meters. The smaller the value, the faster the walking speed, which may represent better balance ability.

    Measured: From enrollment to the end of treatment at 2 weeks

  14. Muscle Strength Indices

    The index includes 2 upper limb muscle strength indexes and 2 lower limb muscle strength indexes, and the formula is as follows:

    1. HS/BM
    2. HS/BMI
    3. Knee extensor strength /BM
    4. Knee flexor strength /BM A higher value for this indicator may mean greater muscle strength.

    Measured: From enrollment to the end of treatment at 2 weeks

  15. Myostatin

    Myostatin is a protein whose units are the same as those of other proteins, usually expressed in moles (mol/L).

    The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, lignin, etc.).

    Measured: From enrollment to the end of treatment at 3 months

  16. Irisin

    The unit of irisin is molecular weight and its value is 298.25.

    The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, lignin, etc.).

    Measured: From enrollment to the end of treatment at 3 months.

  17. BDNF

    BDNF (brain-derived neurotrophic factor) assay unit is mainly pg/mL.

    The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, lignin, etc.).

    Measured: From enrollment to the end of treatment at 3 months.

Timeline

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

  1. First posted5 Dec 2024
  2. Study start1 Jun 2023
  3. Primary completion15 Jul 2024
  4. Study completion15 Jul 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06718023
Sponsor's protocol ID
AWFiS/2023_7_ZO
Other IDs
without grant number
Acronym
PA&SP
Status last verified
Dec 2024
First submitted
29 Oct 2024
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: There are some privacy concerns

Publications

  • 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.

    PubMed 27942207
  • 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.

    PubMed 39221163
  • 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.

    PubMed 20392703
  • Gorbatov SY, Aksenova EI, Burkovskaya YV, Ivanov AV, Gazheva AV. [Global demographic problem and active aging (literature review)]. Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2023 Oct;31(Special Issue 2):1109-1114. doi: 10.32687/0869-866X-2023-31-s2-1109-1114. Russian.

    PubMed 38069871
  • 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.

    PubMed 19801098
  • 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.

    PubMed 30185958

Questions about this trial

What is this clinical trial studying?

A study testing Nordic walking, Strength training and Bungy Pump Exercises in people with Sarcopenia, run by Gdansk University of Physical Education and Sport at 1 site in Poland.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2024. 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 Poland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Skeletal muscle index (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 4 primary outcomes in all. 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 NCT06718023, which also lists 6 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 5 Dec 2024.

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