Integrated Physical Training With Protein Diet in Older Adults With Sarcopenia Symptoms.

Sarcopenia Clinical Trial

Official title:

Comparative Effects of Integrated Physical Training With High Protein Diet Versus Low Protein Diet in COVID-19 Asymptomatic Older Adults With Sarcopenia Symptoms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224453
• Other study ID #: RHPT/020/051
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2022
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sarcopenia is the major health concern and common consequence of COVID-19 in the aging population. Moreover, this clinical condition has not been considered in usual physical rehabilitation practice, and its optimal protein requirement in food is not well defined, which requires a meaningful study in this field. The reports of this trial would deliver the latest evidence and proper guidelines for the prescription of physical exercises and also provide an optimal dietary plan in sarcopenia patients with COVID infection.

Objective: To find and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low-protein diet in community-dwelling COVID-19 asymptomatic older adults with Sarcopenia symptoms.

Description:

It is a single-blinded, randomized, experimental study performed from March -2020 to November-2021. The trial received acceptance from the department of the ethical committee (DEC), Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia with an approval number of RHPT/020/51. The DEC approved the subject consent form, treatment protocols, and the outcome parameters measured in the trial. The trial was executed in accordance with the ethical guidelines laid down in the 1964 Declaration of Helsinki. The finally selected subjects for the trial were asked to fill out the written subject consent form and underwent measurements for pre-interventional personal and anthropometric data. A two-block simple random sampling method was used to randomize and allocated the participants into two treatment groups. Group A was treated with integrated physical training with a high protein diet (n = 38) and group B was treated with the same integrated physical training with a low protein diet (n = 38) for a duration of eight weeks.

Subjects' personal and anthropometric measurements were calculated through Kolmogorov-Smirnov test for testing homogeneity and the data were represented in tabular form. The measurements were taken before the intervention, during the intervention at 4 weeks, after intervention at 8 weeks and after 6 months follow up. The data were shown as mean and standard deviation with 95% confidence interval (CI) with upper and lower limits. The time and group (4 × 2) multiple analysis of variance (MANOVA) of primary and secondary variables are reported between group A and group B at various intervals. The student's t-test was used to calculate inter-group effects and repeated measures (rANOVA) were used to calculate the intra-group effects. IBMSPSS - online version 20 was used to do all the statistical tests and the α level was set at 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

Sarcopenia was diagnosed according to the guidelines given by the Asian working group for Sarcopenia (AWGS).

Appendicular skeletal muscle mass index (ASMI< 7.0 kg/m2) Patients with less muscle mass, Low handgrip strength (< 24 kg) Decrease walking speed (< 0.7 m/sec)

Exclusion Criteria:

Subjects with a history of physical workout, Taking medicines Recent surgeries Joint problems in the leg Heart and lung problems Neurological issues Other systemic diseases Contraindications for physical training

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Physical training and high protein diet
In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (>1 g/kg aBW/d)
• Physical training and low protein diet
In addition to the integrated physical training exercises, group B received low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (<1 g/kg aBW/d)

Locations

Country	Name	City	State
Saudi Arabia	Dr. Gopal Nambi	Al Kharj	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University	Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hand Grip Strength	The test is easy to perform and a less expensive one. It measures the strength of upper extremity by using a device handheld dynamometer. The participant was instructed to press the hand piece of the dynamometer to the maximum of his ability and the values shown on the display were recorded. Three values were noted for each participant and the mean value was considered for interpretation and it is a reliable and valid tool to measure the strength of upper extremity.	At baseline and at 6 months
Secondary	Change in Muscle Cross Sectional Area	Muscle CSA is measured with Magnetic resonance imaging (MRI) scan and it is an expensive measurement. The CSA of three major muscle such as;half way at arm - biceps, thigh - quadriceps and calf muscles were measured and included for analysis.	At baseline and at 6 months
Secondary	Changes in Kinesiophobia	Tampa scale of kinesiophobia questionnaire - Tampa scale of kinesiophobia questionnaire was administered to find the level of fear of movement of participants. The questionnaire has eleven items, which measures the mindset at various activities on a four-point Likert scale (1- Strongly disagree, 2 - Disagree, 3 - Agree, 4 - Strongly agree). The maximum score indicates a high level of fear whereas the minimum score indicates a low level of fear during activities, where 11-21 means no kinesiophobia, 22-27 mild kinesiophobia, 28-33 moderate kinesiophobia, and 34-44 means severe kinesiophobia.	At baseline and at 6 months
Secondary	Changes in Quality of Life	Sarcopenia quality of life (SarQol) questionnaire: The sarcopenia quality of life (SarQol) questionnaire was used to measure the subjects' wellbeing. The participants filled out the questionnaire themselves and it is a robust tool to measure Quality of life. The maximum score indicates a high level of quality of life, whereas the minimum score indicates a low level of quality of life. The total scoring indicates 0-20: worst health, 21-40: poor health; 41-60: fair 61-80: good, and 81-100, best health.	At baseline and at 6 months