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Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation

5. Juli 2026 aktualisiert von: Doaa Mohammed Mahmoud Allam, Cairo University

Effects of Core-Based Movement and Nutritional Counselling on Stress, Cortisol, and Lipid Profiles in Overweight Women With Functional Constipation

This study will investigate the effect of core-based movement and nutritional counselling on stress, serum cortisol, and lipid profile in overweight women with functional constipation.

Sixty overweight women with functional constipation will be randomly assigned into two equal groups. The study group will include 30 participants who will receive a core-based movement exercise program for 8 weeks, two sessions per week, in addition to guideline-based nutritional counselling. The control group will include 30 participants who will receive guideline-based nutritional counselling only for 8 weeks.

The outcomes will include perceived stress, serum cortisol level, lipid profile, stool form, sleep quality, and quality of life.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The practical part of the study will be conducted over 8 weeks, with two sessions per week. Measurements will be taken at baseline before the start of the treatment program and after completion of the 8-week intervention.

A- Evaluative procedures will include

  1. Laboratory investigations for serum cortisol and lipid profile. Blood samples will be collected after an overnight fasting period of 8-12 hours, and 5 mL of venous blood will be drawn from each participant.
  2. Stool form and consistency will be assessed using the Bristol Stool Form Scale, and participants will be instructed to record their bowel movements and stool consistency.
  3. Perceived stress will be assessed using the Perceived Stress Scale.
  4. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
  5. Health-related quality of life will be assessed using the 12-Item Short Form Health Survey.

B- Treatment procedures All participants in both groups will receive nutritional counselling for overweight management and functional constipation. The nutritional counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) and the British Dietetic Association (BDA).

  1. Participants in Group A, the study group, will participate in an 8-week core stability-based movement program, two sessions per week, for a total of 16 sessions. They will also receive guideline-based nutritional counselling. Each exercise session will include 5 minutes of warm-up exercises before the core stability-based movement program and 5 minutes of cool-down stretching exercises after the session to ensure participant safety.
  2. Participants in Group B, the control group, will receive guideline-based nutritional counselling only for 8 weeks. The counselling will be based on guidance provided by NICE for overweight management and BDA for dietary management of functional constipation.

C- Statistical analysis : Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 25 for Windows. Descriptive statistics will be used to describe the data. Mixed-model ANOVA will be used to determine within-group changes and between-group differences. The level of significance for all statistical tests will be set at p < 0.05.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Alaa M ElMoatasem, Assistant professor
  • Telefonnummer: +2 0 10 06625054
  • E-Mail: doaaallam48@gmail.com

Studienorte

  • Ägypten
    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh, Kafr el-Sheikh Governorate, Ägypten, 33511
        • Faculty of Physical Therapy, Kafrelsheikh University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Female participants diagnosed with functional constipation according to Rome IV diagnostic criteria.

Age between 18 and 45 years.

Body mass index between 25 and 29.9 kg/m².

Ability to participate safely in the core-based movement exercise program.

Willingness to follow the nutritional counselling program and study procedures.

Exclusion Criteria:

Participants will be excluded if they have any organic gastrointestinal disorder or any disease that may affect gastrointestinal transit or colonic function.

Participants with inflammatory bowel disease, concurrent infectious enteritis, malignant tumors, or a history of gastrointestinal surgery, including resection of the stomach, small intestine, or large intestine, will be excluded.

Participants receiving steroids, antibiotics, immunosuppressive medications, or routinely using laxatives will be excluded.

Participants with hyperthyroidism, hypothyroidism, or other endocrine or metabolic disorders that may affect gastrointestinal function will be excluded.

Participants with serious cardiovascular, respiratory, renal, hepatic, hematological, neurological, or psychiatric disorders will be excluded.

Participants with a history or current evidence of alcohol abuse within the previous year will be excluded.

Participants currently engaged in an intense workout regimen will be excluded.

Participants with musculoskeletal disability that may interfere with exercise applicability, such as cervical or lumbar radiculopathy, will be excluded.

Exclusion Criteria:

-

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Nutritional Counselling Only
Each participant in this group will receive NICE- and BDA guideline-based nutritional counselling only for overweight management and functional constipation for 8 weeks.
Verhalten: Guideline-Based Nutritional Counselling
Participants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.
Experimental: Core-Based Movement and Nutritional Counselling
Participants in this group will receive an 8-week core-based movement exercise program, two sessions per week, in addition to NICE- and BDA guideline-based nutritional counselling for overweight management and functional constipation.
Verhalten: Guideline-Based Nutritional Counselling
Participants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.
Verhalten: Core-Based Movement Exercise Program

A core-based movement exercise program will include Swan, one leg up-down, leg circles, single-leg stretch, Saw, side kicks, The Hundred, pelvic lift on the ball, sit-ups with the ball, and stretching on the ball. During the first month, sessions 1-8, participants will perform 1 set of 8 repetitions. During the second month, sessions 9-16, participants will perform 2 sets of 10 repetitions.

Guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Serum Cortisol Level
Zeitfenster: Baseline and after 8 weeks
Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12 hour overnight fast.
Baseline and after 8 weeks
Change in Perceived Stress Score
Zeitfenster: Baseline and after 8 weeks
Perceived stress will be assessed using the Perceived Stress Scale.
Baseline and after 8 weeks
Change in Lipid Profile Parameters
Zeitfenster: Baseline and after 8 weeks
Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Baseline and after 8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Stool Form and Consistency
Zeitfenster: Baseline and after 8 weeks
Stool form and consistency will be assessed using the Bristol Stool Form Scale. Participants will record their bowel movements and stool consistency.
Baseline and after 8 weeks
Change in Sleep Quality
Zeitfenster: Baseline and after 8 weeks
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index
Baseline and after 8 weeks
Change in Health-Related Quality of Life
Zeitfenster: Baseline and after 8 weeks
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey.
Baseline and after 8 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cairo University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

25. August 2026

Primärer Abschluss (Geschätzt)

30. März 2027

Studienabschluss (Geschätzt)

30. März 2027

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • FPTBSUREC/0513/14526

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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