Trial Outcomes & Findings for Integrated Physical Training With Protein Diet in Older Adults With Sarcopenia Symptoms. (NCT NCT05224453)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

At baseline and at 6 months

Results posted on

2022-02-17

Participant Flow

01-03-2020 to 30-11-2021 at Department of Physical therapy, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia

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.

Participant milestones

Participant milestones
Measure	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).	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)
Overall Study STARTED	38	38
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Training and High Protein Diet n=38 Participants 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).	Physical Training and Low Protein Diet n=38 Participants 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 n=76 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 3.8 • n=38 Participants	64.5 years STANDARD_DEVIATION 3.6 • n=38 Participants	64.3 years STANDARD_DEVIATION 3.7 • n=76 Participants
Sex: Female, Male Female	00 Participants n=38 Participants	00 Participants n=38 Participants	0 Participants n=76 Participants
Sex: Female, Male Male	38 Participants n=38 Participants	38 Participants n=38 Participants	76 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height (m)	1.64 metre STANDARD_DEVIATION 0.23 • n=38 Participants	1.68 metre STANDARD_DEVIATION 0.25 • n=38 Participants	1.66 metre STANDARD_DEVIATION 0.24 • n=76 Participants
Weight (kg)	78.8 kilogram STANDARD_DEVIATION 4.3 • n=38 Participants	79.2 kilogram STANDARD_DEVIATION 3.8 • n=38 Participants	79.0 kilogram STANDARD_DEVIATION 4.0 • n=76 Participants
BMI (kg/m^2 )	23.2 kg/m^2 STANDARD_DEVIATION 1.8 • n=38 Participants	23.4 kg/m^2 STANDARD_DEVIATION 1.9 • n=38 Participants	23.3 kg/m^2 STANDARD_DEVIATION 1.85 • n=76 Participants
VO2peak (ml/kg/min)	30.8 ml/kg/min STANDARD_DEVIATION 1.9 • n=38 Participants	31.1 ml/kg/min STANDARD_DEVIATION 1.6 • n=38 Participants	30.9 ml/kg/min STANDARD_DEVIATION 1.7 • n=76 Participants
HR (beats/min)	78.1 beats/min STANDARD_DEVIATION 4.5 • n=38 Participants	79.2 beats/min STANDARD_DEVIATION 4.6 • n=38 Participants	78.6 beats/min STANDARD_DEVIATION 4.55 • n=76 Participants

PRIMARY outcome

Timeframe: At baseline and at 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Physical Training and High Protein Diet n=36 Participants 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).	Physical Training and Low Protein Diet n=35 Participants 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)
Changes in Hand Grip Strength At Baseline	29.2 kg Standard Deviation 2.5	29.5 kg Standard Deviation 2.4
Changes in Hand Grip Strength At 6 months	35.3 kg Standard Deviation 2.8	30.3 kg Standard Deviation 2.5

SECONDARY outcome

Timeframe: At baseline and at 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Physical Training and High Protein Diet n=36 Participants 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).	Physical Training and Low Protein Diet n=35 Participants 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)
Change in Muscle Cross Sectional Area MRI - mid arm: At baseline	54.9 cm^2 Standard Deviation 4.2	55.1 cm^2 Standard Deviation 4.3
Change in Muscle Cross Sectional Area MRI - mid arm: At 6 months	58.9 cm^2 Standard Deviation 4.7	57.2 cm^2 Standard Deviation 4.7
Change in Muscle Cross Sectional Area MRI - mid thigh: At baseline	65.2 cm^2 Standard Deviation 5.5	64.9 cm^2 Standard Deviation 5.4
Change in Muscle Cross Sectional Area MRI - mid thigh: At 6 months	71.2 cm^2 Standard Deviation 6.4	67.5 cm^2 Standard Deviation 6.0
Change in Muscle Cross Sectional Area MRI - mid calf: At baseline	61.8 cm^2 Standard Deviation 4.7	60.9 cm^2 Standard Deviation 4.6
Change in Muscle Cross Sectional Area MRI - mid calf: At 6 months	67.2 cm^2 Standard Deviation 5.3	62.8 cm^2 Standard Deviation 5.2

SECONDARY outcome

Timeframe: At baseline and at 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Physical Training and High Protein Diet n=36 Participants 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).	Physical Training and Low Protein Diet n=35 Participants 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)
Changes in Kinesiophobia At baseline	32.5 units on a scale Standard Deviation 3.3	32.7 units on a scale Standard Deviation 3.4
Changes in Kinesiophobia At 6 months	14.2 units on a scale Standard Deviation 1.6	22.3 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: At baseline and at 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Physical Training and High Protein Diet n=36 Participants 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).	Physical Training and Low Protein Diet n=35 Participants 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)
Changes in Quality of Life At baseline	57.1 units on a scale Standard Deviation 5.9	58.0 units on a scale Standard Deviation 5.8
Changes in Quality of Life At 6 months	68.2 units on a scale Standard Deviation 5.9	61.9 units on a scale Standard Deviation 6.1

Adverse Events

Physical Training and High Protein Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Training and Low Protein Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gopal Nambi

Prince Sattam bin Abdulaziz University

Phone: 0501878382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place