- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Isha butt butt, DPT
- Telefonnummer: 03324390215
- E-post: ishamb.09876@gmail.com
Studiesteder
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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: |
|
Aktiv komparator: 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.
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Manual muscle testing (MMT) for strength measurement
Tidsramme: 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
|
baseline to 4 week
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sabiha Arshad, MS, Riphah International University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/RCR&AHS/25/0217
Plan for individuelle deltakerdata (IPD)
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