Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000608864
Ethics application status
Approved
Date submitted
22/04/2020
Date registered
21/05/2021
Date last updated
21/05/2021
Date data sharing statement initially provided
21/05/2021
Date results information initially provided
21/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of circuit hydraulic weight-interval training on body fat, muscle mass and progression of resistance in pre- and postmenopausal women
Scientific title
Effects of circuit hydraulic weight-interval training on body fat, muscle mass and progression of resistance in pre- and postmenopausal women
Secondary ID [1] 301075 0
Nil known
Universal Trial Number (UTN)
U1111-1250-4356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 317143 0
Overweight 317144 0
Sarcopenia 317145 0
Condition category
Condition code
Reproductive Health and Childbirth 317911 317911 0 0
Menstruation and menopause
Musculoskeletal 317912 317912 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study was carried out at the Sports Centre for Women - JollyFit in Wroclaw (Poland). Participants recruited for the project were women aged between 35 – 69 years old from an urban population, who for at least a year had not taken part in any type of resistance or circuit workout and declared their regular involvement in the study training sessions. At recruitment, the subjects were divided into pre- and postmenopausal groups. After enrolling for the study, the participants of both: pre- and postmenopausal groups, were randomly assigned to either training or a control group.
All persons consented in writing to take part in the study. The research project was approved by the local Research Ethics Committee. The participants declared that they would not change their diet throughout the study period of 18 weeks or attend any other physical activity exceeding their regular, daily level of activity. Before the first exercise session, there was organised a training, regarding the appropriate position on each hydraulic machine and the proper manner of exercise. During each subsequent session, a personal trainer supervised the exercise and corrected the body position.
Each participant had their body height (cm), body mass (kg), the circumferences of waist (cm), hips (cm), right thigh (cm), and right upper arm (cm) measured. The indexes of BMI and WHR were calculated. Body fat (%) and muscle mass (kg) were estimated, applying a bioimpedance method with the usage of TANITA BC-418MA analyser (Japan) with GMON software - version 3.1.8.
Muscle performance was determined by the maximum number of repetitions an exercise on each of eight hydraulic machines used in the study. In both experimental age groups the measurements were made before the series of exercise, then after 6, 12 and 18 weeks of training. At each stage of the study, the effects of exercises were discussed with the participants and another training aim was established. In the control group, the measurement were done before and after the intervention.
Training lasted 18 weeks and the subjects performed three workouts per week. Each participant took part in a total of 54 training sessions during the study. Exercises were conducted in two age groups: pre- and postmenopausal, under a constant supervision of a qualified trainer. The study included women who met the criterion of participation in the classes 3 times a week. Session attendance checklists were checked by the trainer to monitor adherence to the intervention. The training protocol consisted of three full workout circuits on the hydraulic gym machines, based on controlled resistance which addressed main muscle groups. The pressure ranges on each machine was set a level of three bars. The exercises were done in a continuous manner, at a maximum effort on the machines, with repeated intervals of 40 seconds, between which there were 40-second-long periods of active rest on the transition stations. The participants were instructed to do as many repetitions as possible on every hydraulic machine. A single training session lasted 32-34 minutes with additional time for stretching. One circuit consisted of eight stations of hydraulic machines and the same number of transition stations set alternately. After each circuit there was a heart rate measurement lasting 10 seconds. A half of the first circuit was treated as a warm-up and the work done was at the level of around 50% of maximum heart rate. Then, after the fourth machine, acceleration took place and at this stage the work was at 60-70% of maximum heart rate. Such a pace was kept until the second half of the third circuit, during which the intensity of exercise and heart rate decreased. After last circuit completion, there was a standard procedure of whole body stretching. In the study following machines with hydraulic resistance were used: pulldown/shoulder press; adductor/abductor; chest press/rowing; hip extension 1 and hip extension 2 ; back extension/flexion (training abdominal and back muscles); butterfly/butterfly reverse, and squat.
Intervention code [1] 317385 0
Prevention
Intervention code [2] 317386 0
Lifestyle
Comparator / control treatment
The control group - women aged between 35 – 69 years old from the same population, they did not participate in training. In this group the measurement were done before and after the intervention, i.e. in the first and 18th week of the programe.
Control group
Active

Outcomes
Primary outcome [1] 323537 0
Change in body composition - muscle mass (kg) as assessed using a TANITA BC-418MA analyser.
Timepoint [1] 323537 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Primary outcome [2] 323538 0
Change in body composition - fat (%) as assessed using a TANITA BC-418MA analyser.
Timepoint [2] 323538 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Primary outcome [3] 325931 0
Anthropometry - change in body weight (kg) as assessed using a calibrated digital scale.
Timepoint [3] 325931 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [1] 382187 0
Anthropometry - change in Body Mass Index (BMI).
BMI is calculated as weight (kg) divided by height (m2). Height measured using a stadiometer and weight measured on an electronic scale.
The outcome is primary.
Timepoint [1] 382187 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [2] 389574 0
Anthropometry - abdominal circumference - using a tape measure to the nearest 0,5 cm.
The outcome is primary.
Timepoint [2] 389574 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [3] 389575 0
Anthropometry - hip circumference as measured by measuring tape to the nearest 0,5 cm.
The outcome is primary.
Timepoint [3] 389575 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [4] 389576 0
Anthropometry - change in Waist-Hip Ratio (WHR).
WHR is calculated as abdominal circumference (cm) divided by hip circumference (cm).
The outcome is primary.
Timepoint [4] 389576 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [5] 389577 0
Anthropometry - thigh circumference as measured by measuring tape to the nearest 0,5 cm.
The outcome is primary.
Timepoint [5] 389577 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [6] 389578 0
Anthropometry - arm circumference as measured by measuring tape to the nearest 0,5 cm.
The outcome is primary.
Timepoint [6] 389578 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [7] 389579 0
Change in muscle performance determined by the an exercise on hydraulic machine: pulldown/shoulder press (maximum number of repetitions).
The outcome is primary.
Timepoint [7] 389579 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [8] 389580 0
Change in muscle performance determined by the an exercise on hydraulic machine: adductor/abductor (maximum number of repetitions).
The outcome is primary.
Timepoint [8] 389580 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [9] 389581 0
Change in muscle performance determined by the an exercise on hydraulic machine: chest press/rowing (maximum number of repetitions).
The outcome is primary.
Timepoint [9] 389581 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [10] 389582 0
Change in muscle performance determined by the an exercise on hydraulic machine: hip extension 1 (maximum number of repetitions).
The outcome is primary.
Timepoint [10] 389582 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [11] 389583 0
Change in muscle performance determined by the an exercise on hydraulic machine: hip extension 2 (maximum number of repetitions).
The outcome is primary.
Timepoint [11] 389583 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [12] 389584 0
Change in muscle performance determined by the an exercise on hydraulic machine: back extension/flexion (maximum number of repetitions).
The outcome is primary.
Timepoint [12] 389584 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [13] 389585 0
Change in muscle performance determined by the an exercise on hydraulic machine: butterfly (maximum number of repetitions).
The outcome is primary.
Timepoint [13] 389585 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.
Secondary outcome [14] 389587 0
Change in muscle performance determined by the an exercise on hydraulic machine: squat (maximum number of repetitions).
The outcome is primary.
Timepoint [14] 389587 0
Baseline, and at 6, 12, and 18 weeks (primary timepoint) after intervention commencement.

Eligibility
Key inclusion criteria
- health condition enabling participation in the project (no contraindications to physical training)
- giving informed written consent
- no participation for the last year in any type of resistance or circuit workout
- no change in diet and non-participation in any other physical activity exceeding regular, daily level of activity throughout the study period of 18 weeks
Minimum age
35 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any extremity or back injury within last one year.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by the sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The urn randomization was done for assigning participants to groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/04/2018
Date of last participant enrolment
Anticipated
Actual
7/06/2019
Date of last data collection
Anticipated
Actual
29/11/2019
Sample size
Target
100
Accrual to date
Final
93
Recruitment outside Australia
Country [1] 22504 0
Poland
State/province [1] 22504 0
Lower Silesia/Wroclaw

Funding & Sponsors
Funding source category [1] 305514 0
University
Name [1] 305514 0
University School of Physical Education in Wroclaw
Country [1] 305514 0
Poland
Primary sponsor type
University
Name
University School of Physical Education in Wroclaw
Address
al. I.J. Paderewskiego 35, 51-612 Wroclaw, Poland
Country
Poland
Secondary sponsor category [1] 305938 0
None
Name [1] 305938 0
Address [1] 305938 0
Country [1] 305938 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305827 0
Senate Ethics Committee of Scientific Research at the University of Physical Education in Wroclaw
Ethics committee address [1] 305827 0
al. I.J. Paderewski 35, 51-612 Wroclaw
Ethics committee country [1] 305827 0
Poland
Date submitted for ethics approval [1] 305827 0
Approval date [1] 305827 0
14/07/2014
Ethics approval number [1] 305827 0

Summary
Brief summary
This study analyzed the effects 18-week-long training program, which join hydraulic resistance with circuit, on anthropometric indices, body fat percentage, muscle mass, and muscle performance in pre- and postmenopausal women. A total of 100 women aged between 35–69 years old were divided by menopausal status, and randomly assigned to training and control groups.
We expect a different response to intervention by physical effort in pre- and post-menopausal women, especially in the range of muscle mass.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101730 0
Dr Malgorzata Socha
Address 101730 0
Department of Human Biology, University School of Physical Education in Wroclaw, al. I.J. Paderewskiego 35, 51-612 Wroclaw
Country 101730 0
Poland
Phone 101730 0
+48 347 33 42
Fax 101730 0
Email 101730 0
[email protected]
Contact person for public queries
Name 101731 0
Dr Malgorzata Socha
Address 101731 0
Department of Human Biology, University School of Physical Education in Wroclaw, al. I.J. Paderewskiego 35, 51-612 Wroclaw
Country 101731 0
Poland
Phone 101731 0
+48 347 33 42
Fax 101731 0
Email 101731 0
[email protected]
Contact person for scientific queries
Name 101732 0
Dr Malgorzata Socha
Address 101732 0
Department of Human Biology, University School of Physical Education in Wroclaw, al. I.J. Paderewskiego 35, 51-612 Wroclaw
Country 101732 0
Poland
Phone 101732 0
+48 347 33 42
Fax 101732 0
Email 101732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.