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

• Sponsor: Prince Sattam Bin Abdulaziz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05224453
• Collaborator: Princess Nourah Bint Abdulrahman University (Other)
• Enrollment: 76
• Location: 1
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Other: Physical training and high protein diet; Other: Physical training and low protein diet	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-blinded, randomized, experimental studySingle-blinded, randomized, experimental study
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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.
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Nov 30, 2021
• Actual Study Completion Date: Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	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 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)	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)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Gopal Nambi	Al Kharj	Riyadh	Saudi Arabia	11942

Sponsors and Collaborators

• Prince Sattam Bin Abdulaziz University
• Princess Nourah Bint Abdulrahman University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Feb 2, 2022

More Information

Publications

None provided.

• Responsible Party: Gopal Nambi, Associate Professor, Prince Sattam Bin Abdulaziz University
• ClinicalTrials.gov Identifier: NCT05224453
• Other Study ID Numbers: RHPT/020/051
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gopal Nambi, Associate Professor, Prince Sattam Bin Abdulaziz University: COVID-19; Sarcopenia; physical training; muscle strength; muscle mass; Quality of life; protein diet
• Additional relevant MeSH terms: Sarcopenia

Study Results

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 Detail	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.

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet
Arm/Group Description	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).	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)
Period Title: Overall Study
STARTED	38	38
COMPLETED	36	35
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet	Total
Arm/Group Description	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).	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)	Total of all reporting groups
Overall Participants	38	38	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (3.8)	64.5 (3.6)	64.3 (3.7)
Sex: Female, Male (Count of Participants)
Female	00 0%	00 0%	0 0%
Male	38 100%	38 100%	76 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Height (m) (metre) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [metre]	1.64 (0.23)	1.68 (0.25)	1.66 (0.24)
Weight (kg) (kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram]	78.8 (4.3)	79.2 (3.8)	79.0 (4.0)
BMI (kg/m^2 ) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.2 (1.8)	23.4 (1.9)	23.3 (1.85)
VO2peak (ml/kg/min) (ml/kg/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/kg/min]	30.8 (1.9)	31.1 (1.6)	30.9 (1.7)
HR (beats/min) (beats/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats/min]	78.1 (4.5)	79.2 (4.6)	78.6 (4.55)

Outcome Measures

1. Primary Outcome

Title	Changes in Hand Grip Strength
Description	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

Outcome Measure Data

Analysis Population Description

At baseline and at 6 months

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet
Arm/Group Description	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).	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)
Measure Participants	36	35
At Baseline	29.2 (2.5)	29.5 (2.4)
At 6 months	35.3 (2.8)	30.3 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Training and High Protein Diet, Physical Training and Low Protein Diet
	Comments
	Type of Statistical Test	Superiority
	Comments	Parametric t test
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -6.21 to -3.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Muscle Cross Sectional Area
Description	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

Outcome Measure Data

Analysis Population Description

At baseline and at 6 months

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet
Arm/Group Description	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).	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)
Measure Participants	36	35
MRI - mid arm: At baseline	54.9 (4.2)	55.1 (4.3)
MRI - mid arm: At 6 months	58.9 (4.7)	57.2 (4.7)
MRI - mid thigh: At baseline	65.2 (5.5)	64.9 (5.4)
MRI - mid thigh: At 6 months	71.2 (6.4)	67.5 (6.0)
MRI - mid calf: At baseline	61.8 (4.7)	60.9 (4.6)
MRI - mid calf: At 6 months	67.2 (5.3)	62.8 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Training and High Protein Diet, Physical Training and Low Protein Diet
	Comments
	Type of Statistical Test	Superiority
	Comments	Parametric t test
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.7
	Confidence Interval	(2-Sided) 95%; -6.53 to -0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Physical Training and High Protein Diet, Physical Training and Low Protein Diet
	Comments
	Type of Statistical Test	Superiority
	Comments	Parametric t test
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -3.84 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Changes in Kinesiophobia
Description	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

Outcome Measure Data

Analysis Population Description

At baseline and at 6 months

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet
Arm/Group Description	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).	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)
Measure Participants	36	35
At baseline	32.5 (3.3)	32.7 (3.4)
At 6 months	14.2 (1.6)	22.3 (2.4)

4. Secondary Outcome

Title	Changes in Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

At 6 months

Arm/Group Title	Physical Training and High Protein Diet	Physical Training and Low Protein Diet
Arm/Group Description	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).	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)
Measure Participants	36	35
At baseline	57.1 (5.9)	58.0 (5.8)
At 6 months	68.2 (5.9)	61.9 (6.1)

Adverse Events

Time Frame	6 months follow-up.
Adverse Event Reporting Description	No adverse reactions were noted.
Arm/Group Title	Physical Training and High Protein Diet		Physical Training and Low Protein Diet
Arm/Group Description	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).		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)
All Cause Mortality
	Physical Training and High Protein Diet		Physical Training and Low Protein Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Serious Adverse Events
	Physical Training and High Protein Diet		Physical Training and Low Protein Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Physical Training and High Protein Diet		Physical Training and Low Protein Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.