NCT05224453

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Prince Sattam Bin Abdulaziz University · Academic / Other
• Sex: Male
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
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)
OTHER	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)

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2022-02-04
• Last updated: 2022-02-17
• Results posted: 2022-02-17

Locations

1 site across 1 country: Saudi Arabia