Home Exercise to Enhance Mobility for Older Diabetics

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01308008
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support; Behavioral: flex and toning health education program	N/A

Detailed Description

The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Home Program to Enhance Mobility in Older Veteran Diabetics
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Functional exercise- home physical activity On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support	Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support; Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
Active Comparator: Flex and tone- home health education Initial on-site flex and toning program continued on follow-up along with health education	Behavioral: flex and toning health education program; Initial flex and toning program continued on follow-up along with health education

Outcome Measures

Primary Outcome Measures

1. Comfortable Gait Speed [1 year]

   Gait velocity over 6 meters

2. Six Minute Walk Distance [one year]

   Walk distance covered in feet over 6 minutes

Secondary Outcome Measures

1. Physical Activity [one year]

   Average physical activity counts per waking minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sedentary

• Type 2 Diabetes

• No medical contraindications to exercise

Exclusion Criteria:

• Enrolled in intensive exercise program

• Unable to cooperate with protocol (e.g. cognitive impairment)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Neil Alexander, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01308008
• Other Study ID Numbers: E7547-R
• First Posted: Mar 3, 2011
• Last Update Posted: Nov 8, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: Type 2 Diabetes Mellitus; Mobility Limitation
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Recruitment Details	Participants were recruited in Ann Arbor, Michigan and surrounding communities. Recruitment relied primarily on media advertisement, community outreach and mailings to patients with diabetes treated at the Veterans Affairs Ann Arbor Healthcare System (VAAAHS) and the University of Michigan (UM), both of which provided IRB approval.
Pre-assignment Detail	Withdrawal after Screening, prior to Baseline: N=5

Arm/Group Title	Functional Exercise- Home Physical Activity	Flex and Tone- Home Health Education
Arm/Group Description	Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support	Initial on-site flex and toning program continued on follow-up along with health education
Period Title: 4 Weeks
STARTED	71	73
COMPLETED	62	71
NOT COMPLETED	9	2
Period Title: 4 Weeks
STARTED	62	71
COMPLETED	54	62
NOT COMPLETED	8	9
Period Title: 4 Weeks
STARTED	54	62
COMPLETED	46	58
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	Functional Exercise- Home Physical Activity	Flex and Tone- Home Health Education	Total
Arm/Group Description	On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support	Initial on-site flex and toning program continued on follow-up along with health education flex and toning health education program: Initial flex and toning program continued on follow-up along with health education	Total of all reporting groups
Overall Participants	71	73	144
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	71 100%	73 100%	144 100%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	69 (6)	70 (6)	70 (6)
Sex: Female, Male (Count of Participants)
Female	22 31%	26 35.6%	48 33.3%
Male	49 69%	47 64.4%	96 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 4.2%	2 2.7%	5 3.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 14.1%	11 15.1%	21 14.6%
White	54 76.1%	58 79.5%	112 77.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 5.6%	2 2.7%	6 4.2%
Comfortable gait speed (meters per second) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters per second]	1.1 (0.2)	1.1 (0.2)	1.1 (0.2)

Outcome Measures

1. Primary Outcome

Title	Comfortable Gait Speed
Description	Gait velocity over 6 meters
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Functional Exercise- Home Physical Activity	Flex and Tone- Home Health Education
Arm/Group Description	Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support	Initial on-site flex and toning program continued on follow-up along with health education
Measure Participants	71	73
Mean (Standard Deviation) [meters per second]	1.2 (0.2)	1.2 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Functional Exercise- Home Physical Activity, Flex and Tone- Home Health Education
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	coefficient
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.02 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Six Minute Walk Distance
Description	Walk distance covered in feet over 6 minutes
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Functional Exercise- Home Physical Activity	Flex and Tone- Home Health Education
Arm/Group Description	Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support	Initial on-site flex and toning program continued on follow-up along with health education
Measure Participants	71	73
Mean (Standard Deviation) [feet]	1307 (234)	1271 (275)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Functional Exercise- Home Physical Activity, Flex and Tone- Home Health Education
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	coefficient
	Estimated Value	34.0
	Confidence Interval	(2-Sided) 95%; -15 to 83
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Physical Activity
Description	Average physical activity counts per waking minute
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Functional Exercise- Home Physical Activity	Flex and Tone- Home Health Education
Arm/Group Description	Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support	Initial on-site flex and toning program continued on follow-up along with health education
Measure Participants	71	73
Mean (Standard Deviation) [counts per minute]	170 (89)	141 (66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Functional Exercise- Home Physical Activity, Flex and Tone- Home Health Education
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	coefficient
	Estimated Value	-8.7
	Confidence Interval	(2-Sided) 95%; -35 to 17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Functional Exercise- Home Physical Activity		Flex and Tone- Home Health Education
Arm/Group Description	Functional exercise- home physical activity		Flex and tone- health education
All Cause Mortality
	Functional Exercise- Home Physical Activity		Flex and Tone- Home Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/73 (0%)
Serious Adverse Events
	Functional Exercise- Home Physical Activity		Flex and Tone- Home Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/71 (4.2%)		3/73 (4.1%)
Infections and infestations
Sepsis	1/71 (1.4%)	1	0/73 (0%)	0
Metabolism and nutrition disorders
hyperkalemia	1/71 (1.4%)	1	0/73 (0%)	0
Musculoskeletal and connective tissue disorders
Partial achilles tendon tear	1/71 (1.4%)	1	0/73 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer	0/71 (0%)	0	1/73 (1.4%)	1
Colonic polyp	0/71 (0%)	0	1/73 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/71 (0%)	0	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Functional Exercise- Home Physical Activity		Flex and Tone- Home Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		2/73 (2.7%)
Musculoskeletal and connective tissue disorders
Baker's cyst drainage	0/71 (0%)	0	1/73 (1.4%)	1
hand pain	0/71 (0%)	0	1/73 (1.4%)	1

Limitations/Caveats

Study completed with depletion of funds.

More Information

Certain Agreements

Principal Investigators are NOT 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.