NCT05496634

Brief Summary

The aim of this study is to investigation of biopsychosocial characteristics of individuals who do pilates and sedentary individuals during the COVID-19 pandemic. The study was carried out with 2 groups: individuals ages 20-50,participating in a pilates program for 8 weeks (n:27) and sedentary individuals (n:27). Before starting this study, the groups were assessed for biopsychosocial status with the Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ) , for depression levels with the Beck Depression Inventory (BDI), for covid-19 fear levels with the Coronavirus Anxiety Scale, for their sleep quality with the Pittsburg Sleep Quality Index (PSQI), quality of life was assessed with the Nottingham Health Profile (NHP). After the first evaluation, an informative presentation emphasizing the importance of physical activity during the pandemic process was given to all participants. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks. At the end of 8 weeks, all questionnaires were repeated for both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable covid19

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

January 5, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

August 5, 2022

Last Update Submit

December 21, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (CETA-BQ)

    It was used to evaluate the biopsychosocial status of the participants. Each item is scored between 0-4 according to the Likert system. An increase in the score indicates a worsening of the biopsychosocial status. (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never)

    0-8 weeks

  • Beck Depression Inventory (BDI)

    Beck Depression Scale consists of 21 items including depressive symptoms. Minimal depression from 0 to 9 points; 10-16 points mild depression; 17-29 points indicate moderate depression and 30-63 points indicate severe depression.

    0-8 weeks

  • Coronavirus Anxiety Scale

    The scale was created by evaluating the scales evaluating different fear parameters by experts and taking into account the opinions of the participants. The scale is scored in a one-factor and five-point Likert type (1=I strongly disagree; 5=I strongly agree). The scale consists of seven items. The score that can be obtained from the scale is between 7-35. A high score indicates greater fear of COVID-19.

    0-8 weeks

  • Pittsburg Sleep Quality Index (PSQI)

    The PSQI consists of 7 components: 1. subjective sleep quality, 2. sleep latency, 3. sleep duration, 4. habitual sleep efficiency, 5. sleep disturbance, 6. sleep medication use, 7. daytime dysfunction. Each component is evaluated with a score between 0-3. The total score is between 0-21. A higher score indicates worsening sleep quality. A score of 0-4 is considered good sleep quality, while a score of 5-21 is defined as poor sleep quality.

    0-8 weeks

  • Nottingham Health Profile (NHP)

    Questionnaire; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items) and emotional reaction (9 items). There are 38 questions in total. Questions are answered with yes or no. Each section is scored between 0-100. Zero indicates best health, 100 indicates worst health.

    0-8 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

An informative presentation will be made emphasizing the importance of physical activity during the pandemic process. Individuals in the exercise group also participated in pilates sessions that lasted 50 minutes, 2 days a week for 8 weeks.

Behavioral: Exercise therapy

Control Group

EXPERIMENTAL

An informative presentation will be made emphasizing the importance of physical activity during the pandemic process.

Behavioral: Sedantary

Interventions

SedantaryBEHAVIORAL

An informative presentation

Control Group

Pilates exercise therapy

Exercise Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 20-50, without any known neurological, mental, vestibular or orthopedic disease,
  • For the exercise group, doing reformer pilates 2 days a week for 8 weeks,
  • For the control group, who is not involved in any physical activity in their daily life (sedentary),
  • Individuals with at least 2 doses of covid-19 vaccine

You may not qualify if:

  • Having orthopedic, neurological or musculoskeletal system problems that prevent him from doing reformer pilates,
  • Not attending the sessions regularly,
  • Pregnancy status or suspected,
  • Covid-19 positive participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Sedentary BehaviorMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Gülay Aras Bayram, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 11, 2022

Study Start

January 5, 2022

Primary Completion

December 12, 2022

Study Completion

December 21, 2022

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations