NCT06727708

Brief Summary

This study aims to compare the effects of two BioCircuit training programmes, 'Tone Your Body' and 'Boost Performance', on physical fitness and body composition in adults aged 30-65 years. Participants will be randomized to one of the two exercise programmes and will undergo a 12-week intervention with baseline and post-intervention measurements of fitness and body composition. The study aims to determine which programme is more effective in improving overall physical fitness, muscle mass and reducing body fat.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 11, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 30, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

Circle TrainingStrength trainingMuscle massBody compositionPhysical fitnessBioCircuitResistance trainingBody fat reductionRandomized controlled trialHandgripstrength

Outcome Measures

Primary Outcomes (4)

  • Change in Skeletal Muscle Mass

    Skeletal muscle mass will be measured using bioimpedance analysis (BIA) at baseline and after the 12-week intervention to evaluate changes in muscle mass.

    Baseline and Week 12

  • Change in Body Fat Percentage

    Body fat percentage will be measured using bioimpedance analysis (BIA) at baseline and after the 12-week intervention to assess reductions in body fat.

    Baseline and Week 12

  • Change in Maximal Strength (10-RM Test)

    Maximal strength will be measured using the 10-RM test on the Smith machine for bench press and leg press at baseline and after the 12-week intervention.

    Baseline and Week 12

  • Change in Handgrip Strength

    Handgrip strength will be measured using a dynamometer at baseline and after the 12-week intervention.

    Baseline and Week 12

Secondary Outcomes (5)

  • Change in Circumference Measurements (Arm, Leg, and Waist)

    Baseline and Week 12

  • Customer Satisfaction (CSAT Questionnaire)

    Week 2 and Week 12

  • Change in Jump and Reach Performance

    Baseline and Week 12

  • Change in Squat Performance (One-Minute Squat Test)

    Baseline and Week 12

  • Change in Push-up Performance (One-Minute Push-up Test)

    Baseline and Week 12

Study Arms (2)

Tone Your Body Group

EXPERIMENTAL

Participants in the Tone Your Body group follow a 12-week BioCircuit training programme designed to improve body composition and muscle toning. The programme consists of six total-body strength exercises and two cardio exercises in a circuit format. Each exercise is performed for 45 seconds, followed by a 40-second rest between machines. The endurance exercises are performed for 3 minutes and 35 seconds each. The eccentric phase of each strength exercise is overloaded by 20% to maximise muscle development.

Device: Tone Your Body BioCircuit Program

Boost Performance Group

EXPERIMENTAL

Participants in the Boost Performance group follow a 12-week BioCircuit training programme designed to increase strength and endurance. The programme consists of six strength exercises and two cardio exercises, also in a circuit format. Each exercise is performed for 45 seconds, with 40 seconds rest between machines, and the endurance exercises are performed for 3 minutes and 35 seconds. The strength exercises use a viscous resistance mechanism to increase strength and endurance. Participants also undergo performance tests including the jump and reach test, one minute squats and one minute push-ups.

Device: Boost Performance BioCircuit Program

Interventions

Participants in the Tone Your Body group follow a 12-week BioCircuit training programme designed to improve body composition and muscle toning. The programme consists of six total-body strength exercises and two cardio exercises in a circuit format. Each exercise is performed for 45 seconds, followed by a 40-second rest between machines. The endurance exercises are performed for 3 minutes and 35 seconds each. The eccentric phase of each strength exercise is overloaded by 20% to maximise muscle development.

Tone Your Body Group

Participants in the Boost Performance group follow a 12-week BioCircuit training programme designed to increase strength and endurance. The programme consists of six strength exercises and two cardio exercises, also in a circuit format. Each exercise is performed for 45 seconds, with 40 seconds rest between machines, and the endurance exercises are performed for 3 minutes and 35 seconds. The strength exercises use a viscous resistance mechanism to increase strength and endurance. Participants also undergo performance tests including the jump and reach test, one minute squats and one minute push-ups.

Boost Performance Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 65 years
  • Healthy individuals without significant medical conditions
  • Less than 6 months of prior strength training experience
  • Willing and able to participate in a 12-week training program
  • Capable of performing strength training exercises such as leg press and chest press
  • Able to provide written informed consent

You may not qualify if:

  • History of coronary heart disease
  • History of stroke
  • Need for changes in antihypertensive treatment within 3 months prior to study start
  • Arthritis
  • Pregnancy or less than three months postpartum
  • Pain and movement restrictions
  • Use of medications that affect muscle strength or performance (e.g., anabolic steroids, beta-2 agonists, glucocorticoids, statins, benzodiazepines, ACE inhibitors, angiotensin-II receptor blockers, diuretics)
  • Any medical condition preventing participation in planned endurance and strength training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CF Leibnitz

Leibnitz, Styria, Styria, 8430, Austria

RECRUITING

Study Officials

  • Martin Atia

    University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This trial uses a randomised parallel group design with minimisation to ensure balanced allocation based on age, gender and baseline handgrip strength. Participants will be assigned to one of two intervention groups, \'Tone Your Body\' or \'Boost Performance\'. Each group follows a 12-week BioCircuit training programme designed to improve physical fitness, muscle strength and body composition. Both programmes include strength and endurance exercises in a circuit format.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2024

First Posted

December 11, 2024

Study Start

October 31, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

December 11, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) used in the published results will be shared in an anonymized format. Access will be provided upon request through a secure data repository for researchers who meet the criteria for access to confidential data.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon publication for one year.

Locations