Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
- 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.
- 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.
- Perceived stress will be assessed using the Perceived Stress Scale.
- Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
- 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).
- 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.
- 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Doaa M Allam, PhD
- Telefonnummer: +2 01003116041
- E-post: doaaallam48@gmail.com
Studer Kontakt Backup
- Navn: Alaa M ElMoatasem, Assistant professor
- Telefonnummer: +2 0 10 06625054
- E-post: doaaallam48@gmail.com
Studiesteder
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33511
- Faculty of Physical Therapy, Kafrelsheikh University
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Ta kontakt med:
- Doaa M Allam, PhD
- Telefonnummer: +2 01003116041
- E-post: Doaa_Alam@pt.kfs.edu.eg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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 a musculoskeletal disability that may interfere with exercise applicability, such as cervical or lumbar radiculopathy, will be excluded.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv 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.
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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.
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Eksperimentell: 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.
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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.
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Serum Cortisol Level
Tidsramme: Baseline and Week 8
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Serum cortisol level will be assessed through laboratory investigation.
Blood samples will be collected after an 8-12-hour overnight fast.
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Baseline and Week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Sleep Quality
Tidsramme: Baseline and week 8
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and a worse outcome.
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Baseline and week 8
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Change in Health-Related Quality of Life
Tidsramme: Baseline and week 8
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Health-related quality of life will be assessed using the 12-Item Short Form Health Survey.
The Physical Component Summary and Mental Component Summary scores are norm-based, with a reference population mean of 50 and a standard deviation of 10.
Higher scores indicate better health-related quality of life.
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Baseline and week 8
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Change in Lipid Profile Parameters
Tidsramme: baseline and week 8
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Description: Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
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baseline and week 8
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Change in Perceived Stress Score
Tidsramme: Time Frame: Baseline and week 8
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Perceived stress will be assessed using the Perceived Stress Scale-10.
The total score ranges from 0 to 40, with higher scores indicating higher perceived stress and a worse outcome.
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Time Frame: Baseline and week 8
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Change in stool form , consistency, and frequency
Tidsramme: Baseline and week 8
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Stool form and consistency will be assessed using the Bristol Stool Form Scale. The scale ranges from Type 1 to Type 7, where Types 1-2 indicate separate hard lumps/constipation, Types 3-4 generally indicate normal stool form, and Types 6-7 indicate watery stool/diarrhea. Weekly stool frequency will be assessed through a daily diary. |
Baseline and week 8
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FPTBSUREC/0513/14526
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