- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360499
Low- Load- High- Repetitions Training Versus Pilates on Physical Fitness in Inactive Women (GetActive)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized exercise intervention study in healthy subjects (adult women-inactive). Participants will be randomly allocated in two groups: the LLHR group and the Pilates group. All assessments will be blinded to the intervention group of the participants. Both exercise programs will be performed in groups lasting for three months and performed 3 times per week. The study conformed to the principles enumerated in the Helsinki Declaration and ethical approval has been obtained by the national ethical committee.
Participants in the LLHR training will participate in a three-month, group based pre-choreographed exercise programme, consisting of three LLHR training sessions per week (in non-consecutive days). All participants will be familiar with the exercises that will be used in this intervention. Each LLHR fitness program, includes a variety of multifunction exercises (i.e. squats, lunges, chest press and chest extension, rowing, triceps extension and bicep curls) addressing all muscle groups; using barbells, dumbbells or body weight. Each session will last for 60 min (including 5 min warm up and 5 min cooldown). Exercise intensity will increase progressively once a month by adding weights to the barbells and dumbbells.
Participants in the Pilates program will be trained with the same exercise schedule for the 3-month period. Their 60 min session, will be consisted of warm-up and cool down (5 minutes each), along with static-isometric exercises addressing major muscle groups. Pilates exercises focus on breathing, concentration, control and precision. Exercise intensity progression in the Pilates program will be performed every one month by increasing the level of demanding of the exercises.
All training sessions of both the LLHR and Pilates programs will be supervised by a qualified sports scientist (one sport scientist responsible for each program) for securing training standardization. Participants in both programs will be advised to avoid taking part in any other exercise session during the intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nicosia, Cyprus, CY2417
- U-Fit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Prior to the initiation of the study, participants will be examined by a physician for confirming their health status. According to the updated criteria, "inactive" is an individual who is performing insufficient amounts of moderate-to-vigorous physical activity (Sedentary Behaviour Research Network, 2012).
Inclusion Criteria:
- Female, inactive, able to participate in an exercise training
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Low-weight-high-repetitions training
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.
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LWHR refers to a specific form of resistance exercise which utilizes low weights and very high repetitions
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Active Comparator: Pilates Training
Pilates exercises focused on breathing, concentration, control and precision.
Participants will be exercised 3 times per week for 3 months in small groups
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Pilates style exercise training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline Aerobic Fitness at 12 weeks
Time Frame: 12 weeks
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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).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline Body Composition at 12 weeks
Time Frame: 12 weeks
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Body fat percentage will be measured using bioelectrical impedance analysis (BIA) (Tanita body composition analyser, TBF-300).
Participants will be asked to avoid any fitness activity, caffeine consumption or eating for 3 hours previous to the test.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline Muscle Strength at 12 weeks
Time Frame: 12 weeks
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Handgrip strength (in kg) of both arms will be measured using a digital dynamometer (T.K.K. 5401 Grip-D; Takey, Tokyo, Japan).
For each arm, the participants will be asked to hold squeeze it for about 3 seconds, whilst no other movement was allowed.
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12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chistoforos Giannaki, PhD, University of Nicosia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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