Sarcopenia
Conditions
Keywords
COVID-19, Sarcopenia, physical training, muscle strength, muscle mass, Quality of life, protein diet
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.
Interventions
OTHERPhysical 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)
OTHERPhysical 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)
Sponsors
Princess Nourah Bint Abdulrahman University
Prince Sattam Bin Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-blinded, randomized, experimental study
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hand Grip Strength | At baseline and at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Cross Sectional Area | At baseline and at 6 months | 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. |
| Changes in Kinesiophobia | At baseline and at 6 months | 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. |
| Changes in Quality of Life | At baseline and at 6 months | 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. |
Countries
Saudi Arabia
Participant flow
Recruitment details
01-03-2020 to 30-11-2021 at Department of Physical therapy, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia
Pre-assignment details
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. Their baseline primary and secondary outcome measures were also measured.
Participants by arm
| Arm | Count |
|---|---|
| Physical Training and High Protein Diet Subjects in this group underwent integrated physical training 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). | 38 |
| Physical Training and Low Protein Diet Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (\<1 g/kg aBW/d) | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Physical Training and High Protein Diet | Physical Training and Low Protein Diet | Total |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 3.8 | 64.5 years STANDARD_DEVIATION 3.6 | 64.3 years STANDARD_DEVIATION 3.7 |
| BMI (kg/m^2 ) | 23.2 kg/m^2 STANDARD_DEVIATION 1.8 | 23.4 kg/m^2 STANDARD_DEVIATION 1.9 | 23.3 kg/m^2 STANDARD_DEVIATION 1.85 |
| Height (m) | 1.64 metre STANDARD_DEVIATION 0.23 | 1.68 metre STANDARD_DEVIATION 0.25 | 1.66 metre STANDARD_DEVIATION 0.24 |
| HR (beats/min) | 78.1 beats/min STANDARD_DEVIATION 4.5 | 79.2 beats/min STANDARD_DEVIATION 4.6 | 78.6 beats/min STANDARD_DEVIATION 4.55 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 00 Participants | 00 Participants | 0 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 76 Participants |
| VO2peak (ml/kg/min) | 30.8 ml/kg/min STANDARD_DEVIATION 1.9 | 31.1 ml/kg/min STANDARD_DEVIATION 1.6 | 30.9 ml/kg/min STANDARD_DEVIATION 1.7 |
| Weight (kg) | 78.8 kilogram STANDARD_DEVIATION 4.3 | 79.2 kilogram STANDARD_DEVIATION 3.8 | 79.0 kilogram STANDARD_DEVIATION 4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
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.
Time frame: At baseline and at 6 months
Population: At baseline and at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Training and High Protein Diet | Changes in Hand Grip Strength | At Baseline | 29.2 kg | Standard Deviation 2.5 |
| Physical Training and High Protein Diet | Changes in Hand Grip Strength | At 6 months | 35.3 kg | Standard Deviation 2.8 |
| Physical Training and Low Protein Diet | Changes in Hand Grip Strength | At Baseline | 29.5 kg | Standard Deviation 2.4 |
| Physical Training and Low Protein Diet | Changes in Hand Grip Strength | At 6 months | 30.3 kg | Standard Deviation 2.5 |
p-value: <0.0595% CI: [-6.21, -3.78]t-test, 2 sided
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.
Time frame: At baseline and at 6 months
Population: At baseline and at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid arm: At 6 months | 58.9 cm^2 | Standard Deviation 4.7 |
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid thigh: At 6 months | 71.2 cm^2 | Standard Deviation 6.4 |
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid arm: At baseline | 54.9 cm^2 | Standard Deviation 4.2 |
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid calf: At baseline | 61.8 cm^2 | Standard Deviation 4.7 |
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid thigh: At baseline | 65.2 cm^2 | Standard Deviation 5.5 |
| Physical Training and High Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid calf: At 6 months | 67.2 cm^2 | Standard Deviation 5.3 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid calf: At 6 months | 62.8 cm^2 | Standard Deviation 5.2 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid arm: At baseline | 55.1 cm^2 | Standard Deviation 4.3 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid arm: At 6 months | 57.2 cm^2 | Standard Deviation 4.7 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid thigh: At baseline | 64.9 cm^2 | Standard Deviation 5.4 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid thigh: At 6 months | 67.5 cm^2 | Standard Deviation 6 |
| Physical Training and Low Protein Diet | Change in Muscle Cross Sectional Area | MRI - mid calf: At baseline | 60.9 cm^2 | Standard Deviation 4.6 |
p-value: <0.0595% CI: [-6.53, -0.86]t-test, 2 sided
p-value: <0.0595% CI: [-3.84, 0.44]t-test, 2 sided
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.
Time frame: At baseline and at 6 months
Population: At baseline and at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Training and High Protein Diet | Changes in Kinesiophobia | At baseline | 32.5 units on a scale | Standard Deviation 3.3 |
| Physical Training and High Protein Diet | Changes in Kinesiophobia | At 6 months | 14.2 units on a scale | Standard Deviation 1.6 |
| Physical Training and Low Protein Diet | Changes in Kinesiophobia | At baseline | 32.7 units on a scale | Standard Deviation 3.4 |
| Physical Training and Low Protein Diet | Changes in Kinesiophobia | At 6 months | 22.3 units on a scale | Standard Deviation 2.4 |
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.
Time frame: At baseline and at 6 months
Population: At 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Training and High Protein Diet | Changes in Quality of Life | At baseline | 57.1 units on a scale | Standard Deviation 5.9 |
| Physical Training and High Protein Diet | Changes in Quality of Life | At 6 months | 68.2 units on a scale | Standard Deviation 5.9 |
| Physical Training and Low Protein Diet | Changes in Quality of Life | At baseline | 58.0 units on a scale | Standard Deviation 5.8 |
| Physical Training and Low Protein Diet | Changes in Quality of Life | At 6 months | 61.9 units on a scale | Standard Deviation 6.1 |