Integrated Physical Training With Protein Diet in Older Adults With Sarcopenia Symptoms.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

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.
    

Intervention name(s): Physical training and high protein diet; Physical training and low protein diet
Intervention type(s): Other; Other
Intervention description(s): 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); 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded, randomized, experimental study
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: COVID-19; Sarcopenia; physical training; muscle strength; muscle mass; Quality of life; protein diet