Trial Outcomes & Findings for Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers (NCT NCT03002155)

NCT ID: NCT03002155

Last Updated: 2022-10-06

Results Overview

Average blood glucose over a three-month period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks post-intervention
• Results posted on: 2022-10-06

Participant Flow

Participants were assigned to study group at the time that the baseline appointment was scheduled for logistical reasons (i.e., to facilitate the identification and enrollment in a community-based exercise course if the participant was allocated to the exercise group). 34 participants were allocated to treatment group, but only 24 attended a baseline session and consented to study participation.

Participant milestones

Measure	Exercise EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control Usual care.
Overall Study STARTED	10	14
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Exercise EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control Usual care.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	0
Overall Study Found to not meet inclusion criteria during baseline session data collection.	1	1

Baseline Characteristics

Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	Exercise n=10 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=14 Participants Usual care.	Total n=24 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 10.0 • n=93 Participants	57.4 years STANDARD_DEVIATION 11.8 • n=4 Participants	58.2 years STANDARD_DEVIATION 10.9 • n=27 Participants
Sex/Gender, Customized Gender · Women	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Sex/Gender, Customized Gender · Men	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	10 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	14 participants n=4 Participants	24 participants n=27 Participants
Time since diabetes diagnosis (self-reported)	20.0 years STANDARD_DEVIATION 14.8 • n=93 Participants	19.1 years STANDARD_DEVIATION 6.8 • n=4 Participants	19.5 years STANDARD_DEVIATION 11.6 • n=27 Participants
Body mass index	32.7 kg/m^2 STANDARD_DEVIATION 5.5 • n=93 Participants	36.4 kg/m^2 STANDARD_DEVIATION 10.8 • n=4 Participants	34.8 kg/m^2 STANDARD_DEVIATION 9.0 • n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks post-intervention

Average blood glucose over a three-month period

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
Glycated Hemoglobin (HbA1c) at 12-week Session	8.0 percentage of HbA1c Standard Deviation 1.7	7.0 percentage of HbA1c Standard Deviation 1.3

PRIMARY outcome

Timeframe: 12 weeks post-intervention

Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on "begin" and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
Chair Stand Test (5x Sit-to-Stand) at 12-week Session	14.4 seconds Standard Deviation 2.8	17.1 seconds Standard Deviation 4.9

SECONDARY outcome

Timeframe: 12 weeks post-intervention

Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
PROMIS-Global at 12-week Session Physical Health	47.5 T-score Standard Deviation 7.5	39.2 T-score Standard Deviation 6.9
PROMIS-Global at 12-week Session Mental Health	50.7 T-score Standard Deviation 10.0	45.7 T-score Standard Deviation 9.1

SECONDARY outcome

Timeframe: 12 weeks post-intervention

Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
PROMIS-Depression at 12 Weeks	48.4 T-score Standard Deviation 8.8	53.8 T-score Standard Deviation 8.7

SECONDARY outcome

Timeframe: 12 weeks post-intervention

Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
PROMIS-Physical Function	44.6 T-score Standard Deviation 7.2	37.0 T-score Standard Deviation 3.2

SECONDARY outcome

Timeframe: Through the end of study participation, approximately 12 weeks

Population: This is a feasibility measure of how many people completed the study from baseline to 12 weeks. Thus, the number of patients that completed the baseline session was used.

Feasibility measure- did the participant attend all study data collection sessions?

Outcome measures

Measure	Exercise n=10 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=14 Participants Usual care.
Retention	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Through the end of study participation, approximately 12 weeks

Feasibility measure- % classes attended by participants in the intervention group

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control Usual care.
Adherence	57.1 percentage of classes attended Standard Deviation 28.9	—

SECONDARY outcome

Timeframe: 12-weeks post-intervention

Population: Only participants in the exercise arm who attended at least one exercise class (n=6 out of 7 total).

Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.

Outcome measures

Measure	Exercise n=6 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control Usual care.
EnhanceFitness Program Evaluation	4.8 score on a scale Standard Deviation 0.32	—

SECONDARY outcome

Timeframe: Through the end of study participation, approximately 12 weeks

Feasibility measure- number of adverse events, if any, that occurred for each participant.

Outcome measures

Measure	Exercise n=7 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control n=11 Participants Usual care.
Adverse Events	0 adverse events	0 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: At the completion of the 2-year study

Population: 34 is the number randomized to group; 40 is the number that we targeted for this study

Feasibility measure- were overall recruitment targets reached? This feasibility measure will be assessed for the overall study and not for each participant.

Outcome measures

Measure	Exercise n=40 Participants EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. EnhanceFitness community exercise program: Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.	Control Usual care.
Recruitment	34 Participants	—

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Sara Morgan, PhD

University of Washington (affiliation)

Phone: 651-229-1719

Email: sjmorgan@uw.edu

Results disclosure agreements

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