- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07646405
Combined Effects of NMES and LIRT on Muscle Strength, Girth, and Physical Endurance in the Geriatric Population
Combined Effects of Neuromuscular Electrical Stimulation and Low-intensity Resistance Training on Muscle Strength, Girth, and Physical Endurance in Geriatric Population
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Informed Consent: Obtain informed consent from participants before starting the study.
2. Demographic Data Collection: Collect demographic data, including age, sex, height, weight, and medical history.
3. Muscle Strength Assessment: Measure muscle strength using a dynamometer (e.g., handgrip strength or knee extension strength).
4. Muscle Girth Measurement: Measure muscle girth using a flexible measuring tape (e.g., mid-upper arm or thigh circumference).
5. 6-Minute Walk Test (6MWT): Conduct the 6MWT to assess physical endurance. Intervention
- NMES Sessions: Administer NMES sessions 2-3 times a week for 4-5 weeks.
- LIRT Sessions: Conduct LIRT exercises 2-3 times a week for 4-5weeks, targeting major muscle groups of upper and lower limb.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Isha butt butt, DPT
- Numéro de téléphone: 03324390215
- E-mail: ishamb.09876@gmail.com
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recrutement
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:• Age: 65 to 85 (35)
- Both male and female will be added(29)
- Patients with low calf muscle mass <31.5 cm for females and <33.5 cm for males will be included in this study(36).
- Participants able to complete the Five Times Sit-to-Stand Test in ≤ 10 seconds (men) or ≤ 11 seconds (women)(37).
- Participants must have ability to walk independently and absence of severe medical conditions(29).
- Participants who takes > 12 seconds to complete TUG will be included in this study(38
Exclusion Criteria:• Participants with contraindications to NMES or RT, such as pacemakers or severe cardiovascular disease(29).
- Participants with a MoCA score of less than 26 will be excluded to ensure adequate cognitive ability to comprehend and follow the study protocol, including exercise and neuromuscular stimulation procedures (39).
- Participants with any musculoskeletal issues will be excluded from this study(35).
- Participants with neuromuscular disorders that may affect muscle strength or function(29).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Neuromuscular electrical stimulation
Prior to the initiation of resistance training, participants will receive 20 minutes of NMES targeting the gastrocnemius and calf muscles Frequency: 35 Hz Pulse duration: 300 µs Following NMES, participants will undergo a 20-minute LIRT session comprising the following exercises: |
Prior to the initiation of resistance training, participants will receive 20 minutes of NMES targeting the gastrocnemius and calf muscles Frequency: 35 Hz Pulse duration: 300 µs Following NMES, participants will undergo a 20-minute LIRT session comprising the following exercises: |
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Comparateur actif: conventinal
5minutes cool-down will be given after allocated interventions to participants of both groups.
Gentle foot massage and stretching relaxation will be included in cool-down.
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Seated Leg Press with Thera Band Resistance (Sole Support Position) Participants will be seated with a Thera Band looped around the soles of their feet and held in the hands to provide resistance during leg extension. Repetitions: 10 Sets: 3 Rest Interval: 30-60 seconds between sets |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Manual muscle testing (MMT) for strength measurement
Délai: baseline to 4 week
|
Muscle strength will be assessed using Manual Muscle Testing (MMT) of the plantar flexors and knee extensors based on the Medical Research Council (MRC) 0-5 grading scale.
Each muscle group will be tested twice on the dominant side, and the higher grade will be recorded.
Participants with grades ≤3 will be classified as having low muscle strength, while those with grades ≥4 will be considered to have sufficient strength for participation in low-intensity resistance training and neuromuscular electrical stimulation (NMES).
MMT is a reliable and widely used clinical method for muscle strength assessment
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baseline to 4 week
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sabiha Arshad, MS, Riphah International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/RCR&AHS/25/0217
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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