Clinical trial NCT05224453: Integrated Physical Training With Protein Diet in Older Adults With Sarcopenia Symptoms.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: COVID-19
Sarcopenia
physical training
muscle strength
muscle mass
Quality of life
protein diet
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2022-02-04
Enrollment: 76
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded, randomized, experimental study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Hand Grip Strength
timeFrame: At baseline and at 6 months
Secondary outcomes:
measure: Change in Muscle Cross Sectional Area
timeFrame: At baseline and at 6 months
measure: Changes in Kinesiophobia
timeFrame: At baseline and at 6 months
measure: Changes in Quality of Life
timeFrame: At baseline and at 6 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Dr. Gopal Nambi
state: Riyadh
Study officials:
References: