Comparative Effects of Integrated Physical Training With High Protein Diet Versus Low Protein Diet in COVID-19 Asymptomatic Older Adults With Sarcopenia Symptoms.
Phase: NA
Conditions: Sarcopenia
Sponsor: Prince Sattam Bin Abdulaziz University

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 registration number: NCT05224453 
Date: 12/02/2022 
 
Study Protocol 
 
Background: 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 nor its optimal protein requirement in food is well defined, which 
requires a meaningful study in this field. 
 
Objective: To find and compare the clinical and psychological effects of integrated physical 
training with a high protein diet versus low-protein diet in community dwelling COVID-19 
asymptomatic older adults with Sarcopenia symptoms.   
 
Design: It is a single-blinded, randomized, experimental study performed during March -2020 to 
November-2021. The trial received acceptance from the department of 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 and was registered in the clinical trial registry with 
registration number NCT05224453. The finally selected subjects for the trial were asked to fill 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. The group A was treated with integrated 
physical training with high protein diet (n = 38) and the group B was treated the same integrated 
physical training with low protein diet (n = 38) for a duration of eight weeks.    
Subjects 
 
Subjects for the study were received from local and government hospitals in Al-Kharj and 
Riyadh region of Saudi Arabia. Positively diagnosis of asymptomatic COVID-19 male patients 

with 60 – 80 years of age was recruited for the study. Appendicular skeletal muscle mass index 
(ASMI< 7.0 kg/m2) was used to identify sarcopenia (skeletal muscle loss). Sarcopenia was 
diagnosed according to the guidelines given by the Asian working group for Sarcopenia (AWGS). 
Patients with less muscle mass, low hand grip strength (< 24 kg) and decrease walking speed (< 
0.7 m/sec) were involved. Subjects with a history of physical workout, taking medicines, recent 
surgeries and joint problems in leg, heart and lung problems, neurological issues, any other 
systemic diseases and contraindications for physical training were eliminated from the study. The 
fig-1 depicts the methods and procedure of involving study subjects in this trial. 
Intervention 
 
Subjects in group-A and Group-B (n=38) underwent integrated physical training for 8 weeks. 
A trained physiotherapist executed the training protocols under proper COVID instructions. The 
training protocol was recorded in treatment logbook and was assessed each session by the study 
supervisor. Prior to the start of exercise training, the basic tests such as; body temperature, blood-
pressure, oxygen saturation rate, heart beat and physical fitness were recorded. If these scores 
exceeded the normal values such as, like body temperature > 38.0oC, blood-pressure > 
150/100mmHg and heart beat>90 beat per min or < 50 beat per min, subjects were asked to refrain 
from training on that session. 
 
The maximum heart rate (MHR) was used to measure the intensity of the given exercise. It 
was found by reducing the subject’s age from number 220. Aerobic training was given with 40 to 
50 percent of maximum heart rate for all the subjects, which is considered as low-intensity aerobic 
training (LAT). Every day, the intervention started with 10mins of stretching of upper and lower 
limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of LAT; consisting 
of 20 mins of treadmill (Axos, Kettler Runner, China) and 10 mins of cycle ergometer (Axos, 
Kettler Runner, China), then with 10 mins of cool down. 
 
All the participants, in both the groups, were prescribed with strength training exercises with 
resistance depends upon each subject’s individual muscle assessment. The ideal resistance for each 
muscle groups were measured based on 1 repetition maximum (1RM) principle. The important 
muscle groups in the spine, upper and lower limb were trained. Each muscle group was undergone 
training for 3 sets consisting 10 repetitions in each set, with a relaxation of 5 mins rest between 
sets. The weight was gradually increased as per the subject and therapist needs and the exercise 
was performed for 4 days in a week for 8 weeks. 

 
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) and 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) as 
prescribed by a qualified nutritionist. 
Outcome measures  
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. 
Muscle cross sectional area - CSA: 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.23 
Kinesiophobia: TSK – 11; 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 in four point likert scale. Maximum score indicates high level of 
fear whereas the minimum score indicates low level of fear during activities. 
Quality of life: Sarcopenia quality of life (SarQol) questionnaire was used to measure the 
subjects’ wellbeing. The participants filled the questionnaire themselves and it is a robust tool to 
measure Qol. 
Sample size  
The sample size for the study was decided based on the report from the study by Yoo Jet 
al. Thirty-five subjects in each group were found by assuming forty percentage mean 
improvement in handgrip strength with standard deviation of 2. By accepting 10% drop of 
subjects at 6 month follow up, two subjects were added in each group. Hence, N=76 subjects 
were selected and divided into two groups with n=38. The sample size was calculated with the 
statistical power at 80% with α level of 0.05. The whole analysis was done with G*Power - 
version 3.1.9.7 software. 
 

Statistical analysis plan 
 
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 intervention, during 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 limit. 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. Student’s t test was used to calculate inter-
group effects and repeated measures (rANOVA) was used to calculate the intra-group effects. 
IBMSPSS – online version 20 was used to do all the statistical tests and α level was set at 0.05. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Informed Consent Form 
 
 
Name of patient: 
 
 
 
 
 
Age/Gender: 
 
Study Title: “Comparative effects of integrated physical training with high protein diet versus low 
protein diet in COVID-19 asymptomatic older adults with Sarcopenia symptoms” 
 
Introduction and Purpose of Study: You have been selected to take part in a study Comparing 
the effects of integrated physical training with high protein diet versus low protein diet in COVID-
19 asymptomatic older adults with Sarcopenia symptoms.  
 
Study Information 
 
Outline of Procedures: At first consultation you will be screened and evaluated for suitability of 
the study. You are requested to attend 4 consultations a week for 4 weeks’ period. If you are taking 
any medication or undergoing any other form of treatment for your back pain, you may be excluded 
from the study.  
Risks and Discomfort: The treatment is safe and is unlikely to cause any adverse side effects. All 
treatments will be performed by qualified physiotherapist. 
Benefits of the study: This study will assist the physiotherapy profession in expanding its 
knowledge of this condition and thus making future treatment of patients suffering from chronic 
low back pain more effective. 
Withdrawal from the Study: You are free to withdraw at any stage with no negative 
repercussions to your health care. 
Remuneration: Patients taking part in the study will not be offered any other form of remuneration 
for taking part in the study. 
Costs of Study: Treatment for the duration of the research process will be free of charge. 
Confidentiality: All patient information and results will be kept confidential and can be shared 
for research purpose if required.  
I have been explained about this research in which I agreed to participate. I know that I am 
giving this consent without any force. I can discontinue the study any time without any reason and 
that will not affect my treatment that I have been informed. My identity can be disclosed for any 

other follow up research. 
 
Signature of Patient  
 
 
 
 
       Signature of Researcher 
 
 
 
I certify that I have explained to the participant about nature, purpose, potential benefits & 
possible risk of the indicated procedure. The information collected will be kept confidential. 
 
 
Signature of Witness  
 
 
 
 
     Signature of Researcher