Womens's HealthNCT05023902
Comparison of Neuromuscular Integrative Activity and Pilates on Sedentary Females
A study testing Pilates and Neuromuscular Integrative Action in people with Womens's Health and Healthy, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of Neuromuscular Integrative Action (NIA) and Pilates exercises on physical fitness and psychological effects in sedentary women. 20-45 years old 43 sedentary females were randomly divided into Pilates and NIA groups. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Womens's Health, Healthy, Sedentary Behavior
- What is being tested?
- Pilates and Neuromuscular Integrative Action
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2017to 21 Feb 2019
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-45 years
- Healthy Females volunteers performed desk jobs 8 hours a day and with a sedentary lifestyle
Who cannot join
- pregnancy,
- using pacemakers or metal implants in their body,
- had an active athlete history, had
- any health problems preventing them performing exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Psychological Effects of Neuromuscular Integrative Activity vs Pilates on Sedentary Females
The aim of this study was to compare the effects of Neuromuscular Integrative Action (NIA) and Pilates exercises on physical fitness and psychological effects in sedentary women. 20-45 years old 43 sedentary females were randomly divided into Pilates and NIA groups. The 6-Minute Walking Test (6MWT), the Sit and Reach Test, and the Static Plunk Test durations were used for the physical fitness level assessment at baseline and at the end of trainings. In addition, the Rosenberg Self-Esteem Scale, the Beck Anxiety Inventory, and the SF-36 were used to evaluate the psycho-somatic symptoms and health-related quality of life of the participants. Both groups received 60-min exercise sessions 2 days a week for 8 weeks.
Read the detailed description
Participant Healthy female volunteers between the ages of 20 and 45 who performed desk jobs 8 hours a day and with a sedentary lifestyle were included in this study. This is a parallel group randomized comparative study aimed to compare the effects of NIA and Pilates on physical fitness and psychological status. This study was conducted at …………. University School of Physical Therapy and Rehabilitation in 2017. Participants were excluded if participants had a risk of pregnancy, using pacemakers or metal implants in participiants' body, had an active athlete history, had any health problems preventing them performing exercises. Written informed consent was obtained from all participants, and participants signed the form approved by the ………………….. University Clinical Research Ethics Committee (020/55134) prior to participation in the study.
Randomization of the volunteers were screened for eligibility and signed an informed consent form. Then, participants were randomized to Pilates and NIA groups using the sealed envelope method. An identification number (i.e., 1-54) was allocated to each volunteer. Each number was written on a separate piece of folded white paper and placed into an opaque envelope. The randomization process was performed by picking a random number from the sealed envelope to allocate each volunteer to either the intervention or control group.
Outcomes Measures This is a prospective, single-blinded, randomized-comparative study, and it involved twice time at pre and post 8-week exercise program. Assessments were performed at the baseline and after eight weeks of intervention. The dependent variables were flexibility, cardiovascular endurance, Abdominal Strength-Endurance, Balance Assessment, self-esteem, anxiety, and quality of life. BMI was measured with a Tanita BC 418 (Tanita Corp., Tokyo, Japan), which is a segmental professional body analysis monitor measuring the impedance generated during the passage of an electric current of 50 kHz, 0.8 mA through tissues.
Psychological Status Rosenberg Self-Esteem Scale The Rosenberg Self-Esteem Scale was developed by Morris Rosenberg and the validity and reliability studies of the Turkish version of the scale were performed by Çuhadaroğlu. The Rosenberg self-esteem scale is a 10-item scale that assesses global self-worth by measuring both positive and negative feelings about the self. Each item has a 4- point Likert scale ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem. The scale was used for self-esteem measurement.
Quality of Life Assessment Short Form Health Survey is a questionnaire assessing the quality of life of the subjects. Short Form Health Survey examines eight different parameters, namely, Functional Capacity, Physical Aspects, Bodily Pain, General Health, Vitality, Social Aspect, Emotional Aspect, and Mental Health domains. A higher score indicates a better quality of life.
Beck Anxiety Inventory The Beck Anxiety Inventory is a 21-item self-report questionnaire for assessing the severity of anxiety. The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression.
Fatigue A Visual Analogue Scale was applied to assess the severity of perceived fatigue. The Visual Analogue Scale is a 10-cm scale that evaluates the severity of fatigue in the previous week.
Physical Fitness Assessment Flexibility Assessment The Sit and Reach Test was used to evaluate the flexibility of the participants. The participants were placed in a long sitting position with straight legs. Participants were asked to lean forward four times and reach forward on the board. At the end of the fourth reach, the distance obtained after participants waited for two seconds was recorded in centimeters (cm).
Cardiovascular Endurance Assessment The cardiorespiratory endurance of the participants was evaluated with the 6 Minute Walk Test. The test was conducted by measuring the distance the participants could walk in a 20-meter corridor with a fast and firm walk. At the beginning of the test, the heart rate and blood pressure of the participants were measured with a pulse meter heart rate monitor. Before the test, the fatigue levels of the participants were assessed by taking the perceived difficulty levels according to the Borg Rating of Perceived Exertion. After the test, evaluations were repeated.
Abdominal Strength-Endurance Assessment Muscle strength and endurance of the abdominal muscles were evaluated by sit-up tests. The participants were placed on participants' back, hips and knees in flexion, with the plantar side of the foot on the bed. The arms were positioned according to the strength of the rectus abdominus muscle and participants were asked to perform trunk flexion for 60 seconds consecutively. The number of trunk flexions completed was recorded. Static abdominal strength and trunk stabilization were evaluated using a static plank test. Individuals assumed a position with the elbows on the ground with the fingertips touching the ground and the hip raised from the ground, and the knee, hip, and trunk were in a parallel line, the maximum time participants could keep this position was recorded. During the test, the participant was asked not to disturb the horizontal position of the trunk.
Balance Assessment The balance of the participants was evaluated with the Functional Reach Test. The test measures dynamic balance and core stabilization. The participants were asked to stretch participants' hands forward while standing and reach from that distance without stepping forward and without support. The distance participants reached was recorded in cm. Interventions The NIA and Pilates programs were implemented by one of the researchers (AU) with trainings and qualifications in both approaches. The trainings were carried out for 60 minutes, 2 days a week, for 8 weeks. Each session was performed by a Pilates instructor with a 10-year of Pilates training experience. NIA sessions were also performed by the same instructor (AA), and she had a 1-year NIA training experience. The participants were asked not to participate in any other physical activity program during the study. Prior to training sessions, a familiarization period of practice was conducted to introduce the participants with the methods and techniques.
Pilates Mat Exercise Protocol The Pilates Mat exercise group followed an eight-week exercise program. The exercise protocol of this study was designed by the researchers. According to previous reports, 6 to 8 weeks of Pilates training has positive effects on physical and psychological health. As the program advanced, 20-cm diameter mini soft balls, Pilates rings, 65 cmdiameter soft gymnastic balls, and rubber bands were used in this order as materials in Pilates exercises. After an initial warm-up exercises at a slow pace for 10 minutes, Pilates exercises with and without equipment were performed for 40 minutes. The exercises ended with a 10-minute recovery and stretching exercises for relaxation of all muscle groups Neuromuscular Integrative Action Protocol NIA includes nine basic movement forms, 13 principles, and 52 basic moves. The nine movement forms were derived from martial arts, dance arts, and the healing arts of the Alexander Technique, Feldenkrais Method, and Yoga. The 13 principles specify areas related to fitness, personal growth, and lifestyle. Centered on the joy of movement, participants focus on, for example, being sensitive to personal rhythms, making the correct movement choices, and experiencing positive changes in daily life. The moves of NIA are used to engage all body areas, improve fitness, and facilitate self-healing. Instrumental music, which plays throughout each 60-min session, is an integrative part of NIA, and the melody and beat of the music used are directly associated with the movements. For instance, the feet and the legs follow a pattern that maps directly on to the drum beat of a particular song, while the arms and the upper body express the melody of the rest of the instruments, such as the guitar, violin, or the singer's voice. Visual imagination is stimulated in NIA as the movements pertaining to the choreography relate a particular image or symbol.
- Conditions
- Womens's Health, Healthy, Sedentary Behavior
- Being tested
- Pilates, Neuromuscular Integrative Action
- Keywords
- Physical Fitness,, Quality of Life, Exercise Therapy, Female
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Pilates has been performed to all participants two times a week in order to compare the effects of NIA
Neuromuscular Integrative ActionOther
Also called NIA Dance
NIA was the experimental group of this study.
| Study group | Role | What they receive |
|---|---|---|
| Pilates | Active comparator | The Pilates Mat exercise group followed an eight-week exercise program. The exercise protocol of this study was designed by the researchers (Table I). According to previous reports, 6 to 8 weeks of Pilates training has positive effects on physical and psychological health (Akbas, Unver, 2021; Bavli \& Koybasi, 2016; Pourvaghar, Bahram, Sharif \& Sayyah, 2014; Rogers \& Gibson, 2009). As the program advanced, 20-cm diameter mini soft balls, Pilates rings, 65 cm diameter soft gymnastic balls, and rubber bands were used in this order as materials in Pilates exercises. After an initial warm-up exercises at a slow pace for 10 minutes, Pilates exercises with and without equipment were performed for 40 minutes. The exercises ended with a 10- minute recovery and stretching exercises for relaxation of all muscle groups Receives: Other: Pilates |
| NIA Dance | Experimental | NIA includes nine basic movement forms, 13 principles, and 52 basic moves. The nine movement forms were derived from martial arts, dance arts, and the healing arts of the Alexander Technique, Feldenkrais Method, and Yoga (Rosas \& Rosas, 2004). The 13 principles specify areas related to fitness, personal growth, and lifestyle. Centered on the joy of movement, they focus on, for example, being sensitive to personal rhythms, making the correct movement choices, and experiencing positive changes in daily life. The moves of NIA are used to engage all body areas, improve fitness, and facilitate self-healing. Receives: Other: Neuromuscular Integrative Action |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self Esteem Scale
The Rosenberg self-esteem scale is a 10-item scale that assesses global self-worth by measuring both positive and negative feelings about the self. Each item has a 4- point Likert scale ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem. The scale was used for self-esteem measurement.
Measured: Change from Baseline Rosenberg Self Esteem scale at 8 weeks
Short Form Health Survey
Short Form Health Survey examines eight different parameters, namely, Functional Capacity, Physical Aspects, Bodily Pain, General Health, Vitality, Social Aspect, Emotional Aspect, and Mental Health domains. A higher score indicates a better quality of life.
Measured: Change from Baseline Short Form Health Survey at 8 weeks
Beck Anxiety Inventory
The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression.
The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression.
Measured: Change from Beck Anxiety Inventory at 8 weeks
Visual Analog Scale and Fatique Evaluation
A Visual Analogue Scale was applied to assess the severity of perceived fatigue. The Visual Analogue Scale is a 10-cm scale that evaluates the severity of fatigue in the previous week.
Measured: Change from Visual Analog Scale at 8 weeks
Secondary outcomes (4)
The Sit and Reach Test
The Sit and Reach Test was used to evaluate the flexibility of the participants. The participants were placed in a long sitting position with straight legs. Participants were asked to lean forward four times and reach forward on the board. At the end of the fourth reach, the distance obtained after participants waited for two seconds was recorded in centimeters.
Measured: Baseline and 8 weeks
6 Minute Walk Test
The cardiorespiratory endurance of the participants was evaluated with the 6 Minute Walk Test. The test was conducted by measuring the distance the participants could walk in a 20-meter corridor with a fast and firm walk. At the beginning of the test, the heart rate and blood pressure of the participants were measured with a pulse meter heart rate monitor. Before the test, the fatigue levels of the participants were assessed by taking the perceived difficulty levels according to the Borg Rating of Perceived Exertion. After the test, evaluations were repeated.
Measured: Baseline and 8 weeks
Sit - Up Test
Muscle strength and endurance of the abdominal muscles were evaluated by sit-up tests. The participants were placed on participants' back, hips and knees in flexion, with the plantar side of the foot on the bed. The arms were positioned according to the strength of the rectus abdominus muscle and participants were asked to perform trunk flexion for 60 seconds consecutively. The number of trunk flexions completed was recorded. Static abdominal strength and trunk stabilization were evaluated using a static plank test. Individuals assumed a position with the elbows on the ground with the fingertips touching the ground and the hip raised from the ground, and the knee, hip, and trunk were in a parallel line, the maximum time participants could keep this position was recorded. During the test, the participant was asked not to disturb the horizontal position of the trunk.
Measured: Baseline and 8 weeks
Functional Reach Tests
The balance of the participants was evaluated with the Functional Reach Test. The test measures dynamic balance and core stabilization. The participants were asked to stretch participants' hands forward while standing and reach from that distance without stepping forward and without support. The distance participants reached was recorded in cm.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start10 Sep 2017
- Primary completion1 Aug 2018
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Womens's HealthStudies of the same condition, open and under way.
- 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
- The volunteers were screened for eligibility and signed an informed consent form. Then, they were randomized to Pilates and NIA groups using the sealed envelope method. An identification number (i.e., 1-54) was allocated to each volunteer. Each number was written on a separate piece of folded white paper and placed into an opaque envelope. The randomization process was performed by picking a random number from the sealed envelope to allocate each volunteer to either the intervention or control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023902
- Sponsor's protocol ID
- YJBMT-D-21-00396
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Psychological Effects of Neuromuscular Integrative Activity vs Pilates on Sedentary Females
- ClinicalTrials.gov ID
- NCT05023902
- Acronym / sponsor ID
- YJBMT-D-21-00396
- Conditions
- Womens's Health, Healthy, Sedentary Behavior
- Keywords
- Physical Fitness,, Quality of Life, Exercise Therapy, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 27 Aug 2021 (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.
The aim of this study was to compare the effects of Neuromuscular Integrative Action (NIA) and Pilates exercises on physical fitness and psychological effects in sedentary women. 20-45 years old 43 sedentary females were randomly divided into Pilates and NIA groups. The 6-Minute Walking Test (6MWT), the Sit and Reach Test, and the Static Plunk Test durations were used for the physical fitness level assessment at baseline and at the end of trainings. In addition, the Rosenberg Self-Esteem Scale, the Beck Anxiety Inventory, and the SF-36 were used to evaluate the psycho-somatic symptoms and health-related quality of life of the participants. Both groups received 60-min exercise sessions 2 days a week for 8 weeks.
Detailed description
Participant Healthy female volunteers between the ages of 20 and 45 who performed desk jobs 8 hours a day and with a sedentary lifestyle were included in this study. This is a parallel group randomized comparative study aimed to compare the effects of NIA and Pilates on physical fitness and psychological status. This study was conducted at …………. University School of Physical Therapy and Rehabilitation in 2017. Participants were excluded if participants had a risk of pregnancy, using pacemakers or metal implants in participiants' body, had an active athlete history, had any health problems preventing them performing exercises. Written informed consent was obtained from all participants, and participants signed the form approved by the ………………….. University Clinical Research Ethics Committee (020/55134) prior to participation in the study.
Randomization of the volunteers were screened for eligibility and signed an informed consent form. Then, participants were randomized to Pilates and NIA groups using the sealed envelope method. An identification number (i.e., 1-54) was allocated to each volunteer. Each number was written on a separate piece of folded white paper and placed into an opaque envelope. The randomization process was performed by picking a random number from the sealed envelope to allocate each volunteer to either the intervention or control group.
Outcomes Measures This is a prospective, single-blinded, randomized-comparative study, and it involved twice time at pre and post 8-week exercise program. Assessments were performed at the baseline and after eight weeks of intervention. The dependent variables were flexibility, cardiovascular endurance, Abdominal Strength-Endurance, Balance Assessment, self-esteem, anxiety, and quality of life. BMI was measured with a Tanita BC 418 (Tanita Corp., Tokyo, Japan), which is a segmental professional body analysis monitor measuring the impedance generated during the passage of an electric current of 50 kHz, 0.8 mA through tissues.
Psychological Status Rosenberg Self-Esteem Scale The Rosenberg Self-Esteem Scale was developed by Morris Rosenberg and the validity and reliability studies of the Turkish version of the scale were performed by Çuhadaroğlu. The Rosenberg self-esteem scale is a 10-item scale that assesses global self-worth by measuring both positive and negative feelings about the self. Each item has a 4- point Likert scale ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem. The scale was used for self-esteem measurement.
Quality of Life Assessment Short Form Health Survey is a questionnaire assessing the quality of life of the subjects. Short Form Health Survey examines eight different parameters, namely, Functional Capacity, Physical Aspects, Bodily Pain, General Health, Vitality, Social Aspect, Emotional Aspect, and Mental Health domains. A higher score indicates a better quality of life.
Beck Anxiety Inventory The Beck Anxiety Inventory is a 21-item self-report questionnaire for assessing the severity of anxiety. The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression.
Fatigue A Visual Analogue Scale was applied to assess the severity of perceived fatigue. The Visual Analogue Scale is a 10-cm scale that evaluates the severity of fatigue in the previous week.
Physical Fitness Assessment Flexibility Assessment The Sit and Reach Test was used to evaluate the flexibility of the participants. The participants were placed in a long sitting position with straight legs. Participants were asked to lean forward four times and reach forward on the board. At the end of the fourth reach, the distance obtained after participants waited for two seconds was recorded in centimeters (cm).
Cardiovascular Endurance Assessment The cardiorespiratory endurance of the participants was evaluated with the 6 Minute Walk Test. The test was conducted by measuring the distance the participants could walk in a 20-meter corridor with a fast and firm walk. At the beginning of the test, the heart rate and blood pressure of the participants were measured with a pulse meter heart rate monitor. Before the test, the fatigue levels of the participants were assessed by taking the perceived difficulty levels according to the Borg Rating of Perceived Exertion. After the test, evaluations were repeated.
Abdominal Strength-Endurance Assessment Muscle strength and endurance of the abdominal muscles were evaluated by sit-up tests. The participants were placed on participants' back, hips and knees in flexion, with the plantar side of the foot on the bed. The arms were positioned according to the strength of the rectus abdominus muscle and participants were asked to perform trunk flexion for 60 seconds consecutively. The number of trunk flexions completed was recorded. Static abdominal strength and trunk stabilization were evaluated using a static plank test. Individuals assumed a position with the elbows on the ground with the fingertips touching the ground and the hip raised from the ground, and the knee, hip, and trunk were in a parallel line, the maximum time participants could keep this position was recorded. During the test, the participant was asked not to disturb the horizontal position of the trunk.
Balance Assessment The balance of the participants was evaluated with the Functional Reach Test. The test measures dynamic balance and core stabilization. The participants were asked to stretch participants' hands forward while standing and reach from that distance without stepping forward and without support. The distance participants reached was recorded in cm. Interventions The NIA and Pilates programs were implemented by one of the researchers (AU) with trainings and qualifications in both approaches. The trainings were carried out for 60 minutes, 2 days a week, for 8 weeks. Each session was performed by a Pilates instructor with a 10-year of Pilates training experience. NIA sessions were also performed by the same instructor (AA), and she had a 1-year NIA training experience. The participants were asked not to participate in any other physical activity program during the study. Prior to training sessions, a familiarization period of practice was conducted to introduce the participants with the methods and techniques.
Pilates Mat Exercise Protocol The Pilates Mat exercise group followed an eight-week exercise program. The exercise protocol of this study was designed by the researchers. According to previous reports, 6 to 8 weeks of Pilates training has positive effects on physical and psychological health. As the program advanced, 20-cm diameter mini soft balls, Pilates rings, 65 cmdiameter soft gymnastic balls, and rubber bands were used in this order as materials in Pilates exercises. After an initial warm-up exercises at a slow pace for 10 minutes, Pilates exercises with and without equipment were performed for 40 minutes. The exercises ended with a 10-minute recovery and stretching exercises for relaxation of all muscle groups Neuromuscular Integrative Action Protocol NIA includes nine basic movement forms, 13 principles, and 52 basic moves. The nine movement forms were derived from martial arts, dance arts, and the healing arts of the Alexander Technique, Feldenkrais Method, and Yoga. The 13 principles specify areas related to fitness, personal growth, and lifestyle. Centered on the joy of movement, participants focus on, for example, being sensitive to personal rhythms, making the correct movement choices, and experiencing positive changes in daily life. The moves of NIA are used to engage all body areas, improve fitness, and facilitate self-healing. Instrumental music, which plays throughout each 60-min session, is an integrative part of NIA, and the melody and beat of the music used are directly associated with the movements. For instance, the feet and the legs follow a pattern that maps directly on to the drum beat of a particular song, while the arms and the upper body express the melody of the rest of the instruments, such as the guitar, violin, or the singer's voice. Visual imagination is stimulated in NIA as the movements pertaining to the choreography relate a particular image or symbol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The volunteers were screened for eligibility and signed an informed consent form. Then, they were randomized to Pilates and NIA groups using the sealed envelope method. An identification number (i.e., 1-54) was allocated to each volunteer. Each number was written on a separate piece of folded white paper and placed into an opaque envelope. The randomization process was performed by picking a random number from the sealed envelope to allocate each volunteer to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Pilates | Active comparator | Other: PilatesThe Pilates Mat exercise group followed an eight-week exercise program. The exercise protocol of this study was designed by the researchers (Table I). According to previous reports, 6 to 8 weeks of Pilates training has positive effects on physical and psychological health (Akbas, Unver, 2021; Bavli \& Koybasi, 2016; Pourvaghar, Bahram, Sharif \& Sayyah, 2014; Rogers \& Gibson, 2009). As the program advanced, 20-cm diameter mini soft balls, Pilates rings, 65 cm diameter soft gymnastic balls, and rubber bands were used in this order as materials in Pilates exercises. After an initial warm-up exercises at a slow pace for 10 minutes, Pilates exercises with and without equipment were performed for 40 minutes. The exercises ended with a 10- minute recovery and stretching exercises for relaxation of all muscle groups |
| NIA Dance | Experimental | Other: Neuromuscular Integrative ActionNIA includes nine basic movement forms, 13 principles, and 52 basic moves. The nine movement forms were derived from martial arts, dance arts, and the healing arts of the Alexander Technique, Feldenkrais Method, and Yoga (Rosas \& Rosas, 2004). The 13 principles specify areas related to fitness, personal growth, and lifestyle. Centered on the joy of movement, they focus on, for example, being sensitive to personal rhythms, making the correct movement choices, and experiencing positive changes in daily life. The moves of NIA are used to engage all body areas, improve fitness, and facilitate self-healing. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-45 years
- Healthy Females volunteers performed desk jobs 8 hours a day and with a sedentary lifestyle
Key exclusion criteria (4 listed)
- pregnancy,
- using pacemakers or metal implants in their body,
- had an active athlete history, had
- any health problems preventing them performing exercises
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 |
|---|---|---|
| PilatesPilates has been performed to all participants two times a week in order to compare the effects of NIA | Other | Pilates |
| Neuromuscular Integrative ActionAlso: NIA DanceNIA was the experimental group of this study. | Other | NIA Dance |
Primary outcome
Rosenberg Self Esteem Scale
Time frame: Change from Baseline Rosenberg Self Esteem scale at 8 weeks
The Rosenberg self-esteem scale is a 10-item scale that assesses global self-worth by measuring both positive and negative feelings about the self. Each item has a 4- point Likert scale ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem. The scale was used for self-esteem measurement.
Short Form Health Survey
Time frame: Change from Baseline Short Form Health Survey at 8 weeks
Short Form Health Survey examines eight different parameters, namely, Functional Capacity, Physical Aspects, Bodily Pain, General Health, Vitality, Social Aspect, Emotional Aspect, and Mental Health domains. A higher score indicates a better quality of life.
Beck Anxiety Inventory
Time frame: Change from Beck Anxiety Inventory at 8 weeks
The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression. The Beck Anxiety Inventory assesses the grade of anxiety using 21 questions. A higher score indicates more severe anxiety and depression.
Visual Analog Scale and Fatique Evaluation
Time frame: Change from Visual Analog Scale at 8 weeks
A Visual Analogue Scale was applied to assess the severity of perceived fatigue. The Visual Analogue Scale is a 10-cm scale that evaluates the severity of fatigue in the previous week.
4 secondary outcomes
The Sit and Reach Test
Time frame: Baseline and 8 weeks
6 Minute Walk Test
Time frame: Baseline and 8 weeks
Sit - Up Test
Time frame: Baseline and 8 weeks
Functional Reach Tests
Time frame: Baseline and 8 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 27 Aug 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Neuromuscular Integrative Action in people with Womens's Health and Healthy, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 27 Aug 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 Turkey (Türkiye). 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?
Rosenberg Self Esteem Scale (time frame: Change from Baseline Rosenberg Self Esteem scale at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.