NCT05023902

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

September 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 5, 2021

Last Update Submit

August 25, 2021

Conditions

Keywords

Physical Fitness,Quality of LifeExercise TherapyFemale

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Change from Visual Analog Scale at 8 weeks

Secondary Outcomes (4)

  • The Sit and Reach Test

    Baseline and 8 weeks

  • 6 Minute Walk Test

    Baseline and 8 weeks

  • Sit - Up Test

    Baseline and 8 weeks

  • Functional Reach Tests

    Baseline and 8 weeks

Study Arms (2)

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

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.

Other: Neuromuscular Integrative Action

Interventions

PilatesOTHER

Pilates has been performed to all participants two times a week in order to compare the effects of NIA

Pilates

NIA was the experimental group of this study.

Also known as: NIA Dance
NIA Dance

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Healthy Females volunteers performed desk jobs 8 hours a day and with a sedentary lifestyle

You may not qualify if:

  • pregnancy,
  • using pacemakers or metal implants in their body,
  • had an active athlete history, had
  • any health problems preventing them performing exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, pHd

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 27, 2021

Study Start

September 10, 2017

Primary Completion

August 1, 2018

Study Completion

February 21, 2019

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations