Trial Outcomes & Findings for Ghrelin Plus Strength Training in Frail Elderly Study (NCT NCT01898611)

NCT ID: NCT01898611

Last Updated: 2019-12-11

Results Overview

The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2019-12-11

Participant Flow

Participant milestones

Measure	Ghrelin Plus Resistance Training Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Overall Study STARTED	5	11
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ghrelin Plus Strength Training in Frail Elderly Study

Baseline characteristics by cohort

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	81.2 years STANDARD_DEVIATION 4 • n=5 Participants	81.6 years STANDARD_DEVIATION 5 • n=7 Participants	81.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in the Short Physical Performance Battery (SPPB)	0.6 units on a scale Standard Deviation 2.1	2.4 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Twelve weeks

Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Treatment-associated Adverse Events	0 events	0 events

SECONDARY outcome

Timeframe: Baseline to twelve weeks

Change in weight from baseline to 12 weeks

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Weight	-0.5 kg Standard Deviation 0.5	0.88 kg Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Total lean body mass by dual energy x-ray absorptiometry

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Lean Body Mass	0.7 kg Standard Deviation 0.8	1.0 kg Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline to 12 weeks

One repetition max bench press

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Muscle Strength	16 kg Standard Deviation 21	29 kg Standard Deviation 25

SECONDARY outcome

Timeframe: Baseline to 12 weeks.

Change in food intake by 3-day food intake record

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Food Intake	298 kcal/day Standard Deviation 127	-81 kcal/day Standard Deviation 128

SECONDARY outcome

Timeframe: Baseline to 12 weeks.

Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Quality of Life	8 score on a scale Standard Deviation 13	4 score on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline to 12 weeks.

According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty

Outcome measures

Measure	Ghrelin Plus Resistance Training n=5 Participants Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=10 Participants Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Change in Frailty Status	3.2 units on a scale Interval 3.0 to 4.0	3.4 units on a scale Interval 3.0 to 4.0

Adverse Events

Ghrelin Plus Resistance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Plus Resistance Training

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ghrelin Plus Resistance Training n=5 participants at risk Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Ghrelin: 2:1 ratio placebo to ghrelin Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.	Placebo Plus Resistance Training n=11 participants at risk Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Resistance training: The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
Blood and lymphatic system disorders Pulmonary embolism	0.00% 0/5	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Anne Cappola, MD

University of Pennsylvania

Phone: 215-573-5359

Email: acappola@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place