Effectiveness of Combined GLP-1 Receptor Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
21. Mai 2026 aktualisiert von: Özgül Öztürk, Acibadem University
Effectiveness of Combined GLP-1 Receptor Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals: a Randomized Controlled Trial Protocol
This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals.
A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone.
The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Pharmacologically induced weight loss with glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists such as tirzepatide is associated with significant reductions in lean body mass, raising concerns regarding muscle function and long-term outcomes. Resistance exercise is the most effective intervention to preserve muscle mass during weight loss; however, evidence combining these approaches is limited.
This study is a prospective, two-center, single-blinded, randomized controlled trial designed to evaluate whether structured resistance exercise enhances muscle preservation and functional outcomes in individuals receiving tirzepatide therapy.
Studientyp
Interventionell
Einschreibung (Geschätzt)
108
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Özgül Öztürk, Associate Professor
- Telefonnummer: 902165004185
- E-Mail: ozgul.ozturk@acibadem.edu.tr
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
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
- body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
- age between 18 and 65 years
Exclusion Criteria:
- diagnosis of type 1 or type 2 diabetes mellitus
- presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
- current participation in a structured diet or exercise program
- use of weight-loss medications within the past 12 months
- history of upper or lower extremity surgery or injury within the past 6 months
- any contraindication to resistance exercise as determined by the treating physician.
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: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Resistance Exercise + Tirzepatide
24-week home-based progressive resistance exercise program (3 sessions/week) using elastic bands and bodyweight exercises, combined with tirzepatide treatment and general lifestyle recommendations..
|
A 24-week home-based resistance exercises using elastic band and bodyweight
Lifestyle recommendations including physical activity and nutritional advice
|
|
Aktiver Komparator: Tirzepatide Alone
Standard tirzepatide treatment with usual care and general lifestyle recommendations.
|
Lifestyle recommendations including physical activity and nutritional advice
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in muscle thickness
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Muscle thickness of the thigh (quadriceps femoris, hamstrings), gastrocnemius, biceps brachii and triceps brachii will be assessed using a portable ultrasound and will be presented in millimeters (mm).
|
Baseline, 12 weeks, 24 weeks
|
|
Muscle echo intensity
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Echo intensity will be assessed via a portable muscle ultrasonography using grayscale analysis (0-255 scale) within a standardized region of interest using ImageJ software (National Institutes of Health, USA), with higher values indicating greater intramuscular fat and fibrous tissue infiltration and thus poorer muscle quality.
Assessments will include four muscle groups: biceps brachii, triceps brachii, quadriceps femoris, and biceps femoris.
|
Baseline, 12 weeks, 24 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Muscle strength (handheld dynamometer)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Isometric muscle strength of the biceps brachii, triceps brachii, quadriceps femoris, and hamstrings will be assessed bilaterally using a Lafayette handheld dynamometer (Lafayette Instrument Company®, USA) using the make test method.
|
Baseline, 12 weeks, 24 weeks
|
|
Body weight
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Body weight will be assessed using bioelectrical impedance analysis and presented in kilograms (kg).
|
Baseline, 12 weeks, 24 weeks
|
|
Six-minute walk test
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using the 6-minute walk test according to standardized procedures and the total distance will be recorded in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Physical activity
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Physical activity will be measured objectively using a wearable device (Garmin Vívosmart 5), time spent for light, moderate, and vigorous activity will be recorded for 7 days.
|
Baseline, 12 weeks, 24 weeks
|
|
Nutritional status (3-day food record)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Dietary intake will be assessed at baseline, 12 weeks, and 24 weeks using 3-day food records (two non-consecutive weekdays and one weekend day).
Prior to assessment, participants will receive standardized verbal, written, and visual instructions - including portion size estimation aids - to ensure accurate and consistent recording.
|
Baseline, 12 weeks, 24 weeks
|
|
Quality of life (Short Form-36)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
The Short Form-36, a validated and reliable self-reported instrument evaluating physical and mental health status across eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health will be used to determine the level of quality of life.
Physical and mental sub scales are scored from 0 to 100, higher scores indicate a better quality of life.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical parameters (blood pressure)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Blood pressure will be measured using a sphygmomanometer at each assessment point.
|
Baseline, 12 weeks, 24 weeks
|
|
Height
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Height of the participants will be assessed using a stadiometer and presented in meters.
|
Baseline, 12 weeks, 24 weeks
|
|
Body mass index
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Body mass index will be calculated using height and weight (kg/m^2)
|
Baseline, 12 weeks, 24 weeks
|
|
Body fat percentage
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Body fat percentage will be assessed using bioelectrical impedance analysis and presented in percentage (%).
|
Baseline, 12 weeks, 24 weeks
|
|
Fat free mass
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Fat-free mass will be assessed using bioelectrical impedance analysis and presented in kilograms.
|
Baseline, 12 weeks, 24 weeks
|
|
Chair stand test
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Functional capacity will be assessed using 30-second chair stand test according to standardized procedures.
The number of repetitions which the participants fully raised from a chair will be recorded in numbers (n).
|
Baseline, 12 weeks, 24 weeks
|
|
Self-reported physical activity
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Self-reported physical activity will be determined using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Metabolic equivalent (MET) values will be calculated and participants will be categorized into inactive, moderately active, and very active based on MET values.
|
Baseline, 12 weeks, 24 weeks
|
|
Grip strength
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Handgrip strength will be assessed using a JAMAR dynamometer (Sammons Preston, USA) following the standardized protocol.
Three maximal isometric contractions will be performed with 1-minute rest intervals, the mean of the three trials in kilograms will be used for analysis.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical measures (fasting glucose)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Fasting glucose will be recorded from the medical records and will be presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
|
Clinical parameters (lipid profile)
Zeitfenster: Baseline, 12 weeks, 24 weeks
|
Total Cholesterol, LDL (Low-Density Lipoprotein) Cholesterol, HDL (High-Density Lipoprotein) Cholesterol, Triglycerides will be recorded from the medical records and presented in mmol/L.
|
Baseline, 12 weeks, 24 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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)
1. November 2026
Primärer Abschluss (Geschätzt)
30. November 2027
Studienabschluss (Geschätzt)
1. Januar 2028
Studienanmeldedaten
Zuerst eingereicht
28. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Mai 2026
Zuerst gepostet (Tatsächlich)
27. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Neuromuskuläre Manifestationen
- Ernährungsstörungen
- Pathologische Zustände, Anatomisch
- Überernährung
- Körpergewicht
- Muskelatrophie
- Atrophie
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Übergewicht
- Fettleibigkeit
- Sarkopenie
- Motorik
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Therapeutika
- Physiotherapiemodalitäten
- Patientenversorgung
- Trainingstherapie
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Körperliche Kondition, menschlich
- Übung
- Widerstandstraining
Andere Studien-ID-Nummern
- Özgül Öztürk
- Grant proposal submitted (Andere Kennung: Acıbadem University)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Individual participant data (IPD) will not be shared.
The study data contains personal health information.
Also, data sharing may also be limited by institutional policies and data protection legislation.
Findings will be reported in aggregate form.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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 .