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Trial registered on ANZCTR

Registration number

ACTRN12621001294842

Ethics application status

Approved

Date submitted

10/11/2020

Date registered

24/09/2021

Date last updated

24/09/2021

Date data sharing statement initially provided

24/09/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparative efficacy of intermittent pneumatic compression and negative pressure therapy on muscle function and soreness. A randomized controlled trial

Scientific title

Comparative efficacy of intermittent pneumatic compression and negative pressure therapy on delayed-onset muscle soreness in young, healthy, physically active men. A randomized controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1260-7055

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

delayed onset muscle soreness (DOMS)

exercise induced muscle damage (EIMD)

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All procedures and therapies were conducted in a laboratory setting in the university research centre. Immediately after DOMS induction (5x20 jumps from a box of 60 cm high) participant performed a session of intermittent compression therapy (ICT) or intermittent negative pressure therapy (INPT) or sham microcurrent therapy (Control) for the lower body (legs and pelvis). A duration of 30 minutes was set for all groups. In all groups, therapy was repeated 24 and 48 hours after DOMS induction. All therapies sessions were provided by an experienced physiotherapist. INPT was performed by Vacusport Regeneration System (Weyergans LTD, Germany) and ICT was performed by BOA - Max 2 (Metrum CryoFlex, Poland). For INPT, program # 2 was used. The program consisted of five six-minute stages. In the first stage, the ratio of the duration of the vacuum and pause, measured in seconds, was 7: 7 at the turbine power level 8, which corresponded to a vacuum of -33 mbar; in the second, respectively 8: 6 and power 10 (- 37mbar); services 8: 8 and 13 (-43mbar); on the fourth 9: 9 and 15 (- 49mbar); on the fifth 10:10 and power 15 (- 49mbar). For ICT sport massage program was set. The pressure in the ventricles corresponded to the diastolic pressure of the examined patients and was in all cases 70-80 mmHg. The "sports massage" program was selected, consisting in pumping three chambers in each leg simultaneously, starting from the distal parts of the lower limbs. 10 treatment cycles were set, with each cycle time being 3 minutes, a typical gradient and a pace of 15. For the potential increase of the massage effect, the option of a pulsating massage was set, which was activated after the chambers were completely filled. After all 24 chambers were inflated, the machine aspirated these chambers simultaneously and the next cycle began.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Sham therapy (simulated microcurrent therapy) was performed using the Sonicator Plus 940 (Mettler Electronics Corporation. Anaheim, USA). Two current circuits were used (both lower limbs). Self-adhesive electrodes were placed on the quadriceps muscle. The procedure lasted 30 minutes without turning on the device. The respondents had no insight into the control panel, and the device did not inform about the elapsed time with sound signals. In all groups, therapy was repeated immediately, 24 and 48 hours after DOMS induction.
All procedures and therapies were conducted by experienced physiotherapists in a laboratory setting in the university research centre.

Control group

Active

Outcomes

Primary outcome [1]

Muscle soreness assessed using a 100mm Visual Analogue Scale (VAS), following pressing a participant’s leg for 3 seconds (central area between the base of the patella and anterior superior iliac spine).

Timepoint [1]

Assessments conducted: prior to and following DOMS induction and in 1h, 24h, and 48h after exercise.
The primary timepoint is 48 hours post eccentric exercise (DOMS induction).

Primary outcome [2]

Maximal isokinetic strength of knee extensors muscles, measured with the use of the Biodex System 4 Pro measuring device (Biodex Medical System, USA). Participants were in a sitting position, pelvis, thighs and trunk stabilised with straps. both legs examined. 5 repetitions in a 60 deg/sec mode.

Timepoint [2]

Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary time point is 48 hours post-DOMS induction.

Primary outcome [3]

Maximal active range of motion-ROM of knee measured with the use of the goniometer. Participants were in a lying position, pelvis and trunk stabilised with straps. both legs examined by physiotherapist

Timepoint [3]

Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary timepoint is 48 hours post DOMS induction

Secondary outcome [1]

Creatine kinase (CK) activity in plasma, Determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland

Timepoint [1]

Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction.

Secondary outcome [2]

Lactic dehydrogenase (LDH) activity in plasma, Determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland

Timepoint [2]

Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction.

Secondary outcome [3]

Additional primary outcome
Maximal isokinetic strength of knee flexor muscles, measured with the use of the Biodex System 4 Pro measuring device (Biodex Medical System, USA). Participants were in a sitting position, pelvis, thighs and trunk stabilised with straps. both legs examined. 5 repetitions in a 60 deg/sec mode.

Timepoint [3]

Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary timepoint is 48 hours post DOMS induction.

Eligibility

Key inclusion criteria

Healthy, moderatey physically active participants. No smoking , no drug taking.

Minimum age

18 Years

Maximum age

28 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

competitive physical activity;
sedentary lifestyle;
lower limb or spine injuries within a year prior to the study;
current inflammations;
contraindications to INPT or ICT

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The randomisationwas conducted using sealed and opaque envelopes to conceal each upcoming allocation during experiment

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants assigned to the groups through randomisation done online on https://www.randomizer.org

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Results are expressed at mean (+/-SD) and were analysed using a repeated measures analysis of variance (ANOVA) to determine time, therapy and interaction effects. A Greenhouse–Geisser correction was done to produce the F ratio adjusting for lack of sphericity in a repeated measures ANOVA. Tukey's post-hoc paired samples t-test was used to determine any differences between trials. The alpha level was accepted at p<0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/11/2018

Date of last participant enrolment

Anticipated

Actual

7/10/2019

Date of last data collection

Anticipated

Actual

11/10/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Biala Podlaska

Funding & Sponsors

Funding source category [1]

University

Name [1]

Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

Address [1]

Akademicka 2, 21-500 Biala Podlaska, Poland

Country [1]

Poland

Primary sponsor type

University

Name

Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

Address

Akademicka 2, 21-500 Biala Podlaska, Poland

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Research Ethics Committee, University of Physical Education, Warsaw, Poland

Ethics committee address [1]

Marymoncka 34, 00-968 Warszawa, Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

01/02/2018

Approval date [1]

13/03/2018

Ethics approval number [1]

SKE 01-02/2018

Summary

Brief summary

The specific aim of this study is to assess if recovery in DOMS syndrome could be accelerated with a use of compression therapy or negative pressure therapy. We hypothesized that therapies would be similarly effective in pain reduction and muscle function improvement. Results will be applicable to athletes and active people. This is the first randomised control trial to evaluate effects of  ICT or INPT on muscle fatigue and recovery during DOMS syndrome.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Szczepan Wiecha

Address

Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska

Country

Poland

Phone

+48 602349181

Fax

[email protected]

Contact person for public queries

Name

Szczepan Wiecha

Address

Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska

Country

Poland

Phone

+48 602349181

Fax

[email protected]

Contact person for scientific queries

Name

Szczepan Wiecha

Address

Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska

Country

Poland

Phone

+48 602349181

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data underlying published results only

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Only researchers

Available for what types of analyses?

Available for statistical analyses with lack of sufficient data in manuscript

How or where can data be obtained?

Principal Investigator, with requirement to sign data access agreement.
Contact by email: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9674	Ethical approval					380865-(Uploaded-10-11-2020-01-30-14)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The efficacy of intermittent pneumatic compression and negative pressure therapy on muscle function, soreness and serum indices of muscle damage: a randomized controlled trial.	2021	https://dx.doi.org/10.1186/s13102-021-00373-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically