NCT04360499

Brief Summary

Low-weight-high-repetitions (LWHR) programs constitute a popular group-based form of exercise for the general population, accompanied by various health benefits for the participants. However, the effect of such programs on cardiorespiratory fitness is still controversial. The aim of the current study was to examine the effects of a 3-month LWHR group exercise program vs pilates on cardiorespiratory fitness, body composition and overall health on previously inactive adult women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

April 13, 2020

Last Update Submit

September 28, 2021

Conditions

Keywords

fitnessbody fattrunk fatsleepPilatesWomen

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline Aerobic Fitness at 12 weeks

    The 20m shuttle run will be used in order to assess aerobic fitness levels (Leger et al., 1988). Briefly, the 20m shuttle run test involves continuous shuttle running, between two parallel lines set exactly at 20m apart, in time to recorded beeps being indicated by signals produced from a commercially available pre-recorded CD (Coachwise Ltd, UK). Initial speed dictated at 8.5 km/h and increased by 0.5 km/h per minute. The test for each participant will be terminated when the participant could no longer maintain the speed-pace, for more than two consecutive beeps. For each participant, the number of shuttles completed will be recorded as an index of their aerobic fitness level (Leger et al., 1988).

    12 weeks

Secondary Outcomes (1)

  • Changes from baseline Body Composition at 12 weeks

    12 weeks

Other Outcomes (1)

  • Changes from baseline Muscle Strength at 12 weeks

    12 weeks

Study Arms (2)

Low-weight-high-repetitions training

EXPERIMENTAL

Low-weight-high-repetitions (LWHR) refer to a specific form of resistance exercise which utilizes low weights and very high repetitions. Participants will be exercised 3 times per week for 3 months in small groups.

Other: Low- weight-high-repetitions training

Pilates Training

ACTIVE COMPARATOR

Pilates exercises focused on breathing, concentration, control and precision. Participants will be exercised 3 times per week for 3 months in small groups

Other: Pilates training

Interventions

LWHR refers to a specific form of resistance exercise which utilizes low weights and very high repetitions

Low-weight-high-repetitions training

Pilates style exercise training

Pilates Training

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInactive but otherwise healthy adult women will participate in the current study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, inactive, able to participate in an exercise training

You may not qualify if:

  • male gender, inability to perform the exercise training program due to musculoskeletal injury, a medication that could affect cardio-metabolic function, including anti-hypertensive, diabetic or anti-obesity drugs and inability to systematically participate in the proposed training programs according to the schedule (i.e. absence from 3 consecutive exercise sessions or missed more than 10% of total exercise sessions), psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U-Fit

Nicosia, CY2417, Cyprus

Location

Related Publications (1)

  • Evangelou C, Sakkas GK, Hadjicharalambous M, Aphamis G, Petrou P, Giannaki CD. The effect of a three month, low-load- high-repetitions group-based exercise program versus pilates on physical fitness and body composition in inactive women. J Bodyw Mov Ther. 2021 Apr;26:18-23. doi: 10.1016/j.jbmt.2020.08.017. Epub 2020 Sep 4.

    PMID: 33992241BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Chistoforos Giannaki, PhD

    University of Nicosia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be aware of the type of exercise intervention. Assessors will be blind for the group allocation of the participants
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated in two groups: the LLHR group and the Pilates group. Both exercise programs will be performed in groups lasting for three months and performed 3 times per week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 24, 2020

Study Start

January 10, 2018

Primary Completion

August 10, 2020

Study Completion

September 10, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Only with other researchers participating in the study

Locations