Sedentary BehaviorGetActiveNCT04360499
Low- Load- High- Repetitions Training Versus Pilates on Physical Fitness in Inactive Women
A study testing Low- weight-high-repetitions training and Pilates training in people with Sedentary Behavior, run by University of Thessaly at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Low- weight-high-repetitions training and Pilates training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Jan 2018to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, inactive, able to participate in an exercise training
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Sedentary Behavior
- Being tested
- Low- weight-high-repetitions training, Pilates training
- Keywords
- fitness, body fat, trunk fat, sleep, Pilates, Women
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low- weight-high-repetitions trainingOther
LWHR refers to a specific form of resistance exercise which utilizes low weights and very high repetitions
Pilates trainingOther
Pilates style exercise training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Pilates training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
Changes from baseline Body Composition at 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 Jan 2018
- Primary completion10 Aug 2020
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nicosia
- Responsible party
- Principal investigator, Giorgos K. Sakkas, University of Thessaly
- Investigators
- Chistoforos Giannaki, PhD, Principal investigator, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360499
- Sponsor's protocol ID
- EEBK/EΠ/2015/34
- Acronym
- GetActive
- Status last verified
- Sep 2021
- First submitted
- 13 Apr 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only with other researchers participating in the study
Publications
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.
PubMed 33992241
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04360499
- Acronym / sponsor ID
- GetActive / EEBK/EΠ/2015/34
- Conditions
- Sedentary Behavior
- Keywords
- fitness, body fat, trunk fat, sleep, Pilates, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Nicosia
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-weight-high-repetitions training | Experimental | Other: Low- weight-high-repetitions trainingLow-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. |
| Pilates Training | Active comparator | Other: Pilates trainingPilates exercises focused on breathing, concentration, control and precision. Participants will be exercised 3 times per week for 3 months in small groups |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female, inactive, able to participate in an exercise training
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low- weight-high-repetitions trainingLWHR refers to a specific form of resistance exercise which utilizes low weights and very high repetitions | Other | Low-weight-high-repetitions training |
| Pilates trainingPilates style exercise training | Other | Pilates Training |
Primary outcome
Changes from baseline Aerobic Fitness at 12 weeks
Time frame: 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).
1 secondary outcome
Changes from baseline Body Composition at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 33992241Evangelou 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.
- Individual participant dataSharing planned: No. Only with other researchers participating in the study
Related trials for Sedentary Behavior
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chistoforos Giannaki, PhD principal investigator
University of Nicosia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low- weight-high-repetitions training and Pilates training in people with Sedentary Behavior, run by University of Thessaly at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline Aerobic Fitness at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.