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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05767541
Other study ID # 2642
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date July 31, 2023

Study information

Verified date March 2023
Source Dow University of Health Sciences
Contact Syeda Ariba Shoaib
Phone +923340037674
Email syedaariba3@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of two exercises to improve physical functioning of older adults with sarcopenia. the primary aim of this RCT is: To measure the influence of pilates exercises versus resistance training in elderly with sarcopenia. To introduce an affordable, effective and safe exercise care program, which prioritizes to make geriatric population independent. Participants will be assessed for all outcome measures at baseline and 3 weeks following an exercise intervention. Participants enrolled in pilates exercise group will receive total of 9 exercises and participants enrolled in resistance exercise group will receive total of 8 exercises.


Description:

A total sample of 70 of geriatric population with sarcopenia will be collected from Dow University Hospital Ojha. Non-probability purposive sampling technique will be used. Participants will be screened and referred from medicine, family medicine and neurology OPD to physiotherapy OPD. Outcome measure assessment will be performed in all patients at two time points: baseline and follow up at the end of last session. Outcome measures include short physical performance battery assessment tool (SPPB). Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five consecutive times and performing the walking speed test (3 meters), Time up and go test, sit and reach test, and 2-minute step test as a measure of physical functioning. After complete assessment at baseline all participants will be randomized to different treatment groups using 70 opaque sealed envelopes containing notes written with "new treatment" or "Standard treatment" on (n= 35 of each). The envelops will be scrambled before each participant allow to draw an envelope and thus find out in which group they will be allocated. Treatment will be provided to both groups. Group 1 will be provided with pilates exercises and group 2 will be provided with resistance exercises. Both groups will perform generalized warm up for up to 10 minutes at the beginning and 10 minutes of relaxation exercises at the end of treatment session.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 31, 2023
Est. primary completion date June 28, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 70 Years
Eligibility Inclusion Criteria: - Referred and screened patients with sarcopenia from medicine, family medicine and neurology OPD at Dow University Hospital Ojha Campus, Karachi. - Patients from 60 to 70 years of age - Both male and female. - Patients who consent to participate Exclusion Criteria: - Being bedridden - Implanted pacemaker - Recent history of any fracture - Patients with cognitive & neurological impairment - Already enrolled in any exercise intervention program - Known case of patients with malignancy - Patients on steroids

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercises
The Pilates technique consist of hundred, swimming, prone leg lift, single leg stretch, spine stretch forward, arm circles, imprint and release, one leg circles and mini squat.
Resistance exercises
Resistance training include leg press, shoulder press, bench press, back arm press, seated row, knee extension, leg curl and seated calf raise

Locations

Country Name City State
Pakistan Dow University of Health and Sciences Karachi Sindh
Pakistan Dow University of Health and Sciences Karachi

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Mueller D, Redkva PE, Fernando de Borba E, Barbosa SC, Krause MP, Gregorio da Silva S. Effect of mat vs. apparatus pilates training on the functional capacity of elderly women. J Bodyw Mov Ther. 2021 Jan;25:80-86. doi: 10.1016/j.jbmt.2020.11.012. Epub 202 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Short physical performance battery assessment tool. The SPPB assesses physical performance through balance, strength, and gait.
.Each test is scored from 0 (inability to perform the task) to 4 points (best test performance).The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance).
3 weeks, change from baseline
Secondary Time up and go test TIME UP AND GO TEST: To evaluate agility and dynamic balance this is essential for tasks that demands quick movements. 3 weeks, change from baseline
Secondary sit and reach test SIT AND REACH TEST: It determines the lower back and hamstring flexibility. Which is necessary for proper gait pattern, good posture and multiple movement task. 3 weeks, change from baseline
Secondary 2-minute step test 2-MINUTE STEP TEST: To assess aerobic fitness. 3 weeks, change from baseline
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