NCT06718023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

October 29, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

sarcopeniapostmenopausal womenNordic walkingStrength trainingBungy Pump Exercises

Outcome Measures

Primary Outcomes (4)

  • Skeletal muscle index

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

    From enrollment to the end of treatment at 2 weeks

  • 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.

    From enrollment to the end of treatment at 2 weeks

  • 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.

    From enrollment to the end of treatment at 2 weeks

  • 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.

    From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (17)

  • Right Arm Lean Mass

    From enrollment to the end of treatment at 2 weeks

  • Left Arm Lean Mass

    From enrollment to the end of treatment at 2 weeks

  • Trunk Lean Mass

    From enrollment to the end of treatment at 2 weeks

  • Right Leg Lean Mass

    From enrollment to the end of treatment at 2 weeks

  • Left Leg Lean Mass

    From enrollment to the end of treatment at 2 weeks

  • +12 more secondary outcomes

Other Outcomes (10)

  • Creatinine

    From enrollment to the end of treatment at 2 weeks

  • Creatine kinase

    From enrollment to the end of treatment at 2 weeks

  • Body Fat Mass

    From enrollment to the end of treatment at 2 weeks

  • +7 more other outcomes

Study Arms (4)

Nordic walking

EXPERIMENTAL

Training 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.

Behavioral: Nordic walking

Daily life

NO INTERVENTION

The individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion.

Strength training

EXPERIMENTAL

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.

Behavioral: Strength training

Bungy Pump Exercises

EXPERIMENTAL

The 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.

Behavioral: Bungy Pump Exercises

Interventions

Nordic walkingBEHAVIORAL

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.

Nordic walking

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.

Strength training

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.

Bungy Pump Exercises

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, 80-336, Poland

Location

Related Publications (6)

  • 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.

    PMID: 27942207BACKGROUND
  • 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.

    PMID: 39221163BACKGROUND
  • 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.

    PMID: 20392703BACKGROUND
  • 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.

    PMID: 38069871BACKGROUND
  • 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.

    PMID: 19801098BACKGROUND
  • 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.

    PMID: 30185958BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Nordic WalkingResistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Zbigniew Ossowski Professor, PHD

    AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

December 5, 2024

Study Start

June 1, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations