WATCH: Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT06013046

Collaborator

(none)

110

Enrollment

Location

Arms

49.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to improve cardiometabolic health outcomes for wheelchair users and identify strategies for achieving sufficient physical activity intensity during bouts of structured physical activity.

Condition or Disease	Intervention/Treatment	Phase
Physical Disability	Behavioral: Intensity-controlled physical activity training (IPAT) Behavioral: Education and Access (EA)	N/A

Detailed Description

Wheelchair users have a higher risk for obesity and cardiometabolic health-related diseases compared to persons without a disability and remain one of the most sedentary populations in the United States. Engaging wheelchair users in physical activity levels following the current recommendations to achieve cardiometabolic health-related changes requires tailoring and supports in an accessible community environment, but it is unclear if a community-based physical activity intervention that also prioritizes intensity levels is best to improve cardiometabolic health. This project will determine the effects and implementation outcomes of a community-based, intensity-controlled aerobic and strength training intervention on the cardiometabolic health of wheelchair users and will significantly advance public health knowledge of how to engage wheelchair uses in physical activity to reverse or prevent cardiometabolic health-related disease.

The aims of the study are to:

Compare the effectiveness of the intensity-controlled physical activity training (IPAT) group to the education and access (EA) group for improving cardiometabolic-related health outcomes.
Identify barriers and facilitators to wheelchair users engaging in physical activity at a community-based accessible gym.
Examine the moderators (i.e., age, race, gender, duration of disability, wheelchair type, and physical function) and mediators (ie., self-efficacy, motivation, and barriers/facilitators) of the proposed intervention to understand for whom and how the intervention was effective.

A hybrid I RCT will be conducted. One hundred and ten individuals with a physical disability requiring the use of a wheelchair will be recruited. Each participant will be randomized into either a 14-week IPAT group (n=56) or a 14-week EA group (n=54). Participants' cardiomrespiratory, body composition, metabolic blood chemistries and strength will be assessed baseline (T1) and post intervention (T2).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health (WATCH): A Community-based Randomized Control Trial

Actual Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intensity-controlled physical activity training (IPAT) A group provided education on physical activity recommendations for people with disabilities, access to a community-based accessible gym, and an intensity-controlled 14-week one-on-one supervised physical activity training intervention.	Behavioral: Intensity-controlled physical activity training (IPAT) The IPAT group will receive 40 (90 minute) one-on-one, intensity-controlled, exercise sessions by trained staff over 14 weeks. The initial 2-week period will include dedicated education on topics including physical activity guidelines and the benefits of achieving them, the feeling of moderate-to-vigorous physical activity intensity levels, and the appropriate exercises for achieving desired intensity levels. Tailored sessions will be created for each participant based on their physical fitness, goals, preferred exercise equipment and results from their baseline assessment. Each session can include vitals, pain assessment, warm-up, aerobic training, strength exercises and a cool-down. The participants will be monitored to ensure they are achieving at least 150 minutes of moderate-to-vigorous intensity physical activity weekly. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. The overall goal is to improve cardiorespiratory fitness.
Placebo Comparator: Education and Access (EA) A group provided education on physical activity recommendations for people with disabilities and access to a community-based accessible gym in order to independently complete a 14-week physical activity program.	Behavioral: Education and Access (EA) The EA group will receive an initial 60 minute educational session, during which they will receive information on the adapted exercise equipment in the Orthwein Center, education on the physical activity guidelines and the health benefits of achieving them, and access to the Orthwein Center accessible gym. They will then complete a 14-week independent workout program with the goal of meeting physical activities guidelines. They will have access to Orthwein Center staff to help with minimal setup and guidance, but sessions will be self-directed. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. Participants will be asked to complete a log for each session to report pain, details of the activities they completed during their workout, the RPE for each activity, and how long each activity lasted.

Arm

Intervention/Treatment

Active Comparator: Intensity-controlled physical activity training (IPAT)

A group provided education on physical activity recommendations for people with disabilities, access to a community-based accessible gym, and an intensity-controlled 14-week one-on-one supervised physical activity training intervention.

Behavioral: Intensity-controlled physical activity training (IPAT)

The IPAT group will receive 40 (90 minute) one-on-one, intensity-controlled, exercise sessions by trained staff over 14 weeks. The initial 2-week period will include dedicated education on topics including physical activity guidelines and the benefits of achieving them, the feeling of moderate-to-vigorous physical activity intensity levels, and the appropriate exercises for achieving desired intensity levels. Tailored sessions will be created for each participant based on their physical fitness, goals, preferred exercise equipment and results from their baseline assessment. Each session can include vitals, pain assessment, warm-up, aerobic training, strength exercises and a cool-down. The participants will be monitored to ensure they are achieving at least 150 minutes of moderate-to-vigorous intensity physical activity weekly. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. The overall goal is to improve cardiorespiratory fitness.

Placebo Comparator: Education and Access (EA)

A group provided education on physical activity recommendations for people with disabilities and access to a community-based accessible gym in order to independently complete a 14-week physical activity program.

Behavioral: Education and Access (EA)

The EA group will receive an initial 60 minute educational session, during which they will receive information on the adapted exercise equipment in the Orthwein Center, education on the physical activity guidelines and the health benefits of achieving them, and access to the Orthwein Center accessible gym. They will then complete a 14-week independent workout program with the goal of meeting physical activities guidelines. They will have access to Orthwein Center staff to help with minimal setup and guidance, but sessions will be self-directed. Heart rate and actigraphy monitors will be worn during sessions to capture exercise intensity data. Participants will be asked to complete a log for each session to report pain, details of the activities they completed during their workout, the RPE for each activity, and how long each activity lasted.

Outcome Measures

Primary Outcome Measures

VO2max - Cardiorespiratory Fitness change (Max Oxygen Consumption Change in ml/kg/min) [Baseline and up to 3 weeks post intervention]
VO2max will be measured in ml/kg/min using a portable, breath-by-breath metabolic system with an optoelectronic reader, as well as reliable highly linear and rapid response O2 and CO2 sensors (COSMED K5, COSMED: The Metabolic Company, Chicago, IL). This testing will be completed while the participant performs a graded-exercise test on a crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp-up protocol which is typically completed in 8-12 minutes, and a subsequent 5-minute recovery phase.

Secondary Outcome Measures

DEXA - Body Composition Overall Body Fat Change (kg) [Baseline and up to 3 weeks post intervention]
Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
DEXA - Body Composition Overall Lean Mass Change (kg) [Baseline and up to 3 weeks post intervention]
Participants will undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety.
Metabolic blood chemistries (fasting glucose and insulin) - Insulin Resistance Change (mg/dL) [Baseline and up to 3 weeks post intervention]
Participants will fast 8-10 hours prior to blood draw. Blood draws will be completed to determine both fasting glucose and fasting insulin. These results will then be used to figure the HOMA-IR score, which is an insulin resistance score in mg/dL .
Brachial artery reactivity test (BART) - Endothelial function change (%) [Baseline and up to 3 weeks post intervention]
Participants will undergo a BART via ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events.

Other Outcome Measures

PROMIS - Change in Pain Intensity (Short Form 3a) [Baseline and up to 3 weeks post intervention]
The Pain Intensity instruments assess how much a person hurts. The pain intensity short forms are not disease specific and assess pain intensity over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "Had no pain (1)" to "very severe (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Fatigue (Short Form 8a) [Baseline and up to 3 weeks post intervention]
The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely impacts one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Has a physical disability requiring the use of a wheelchair (includes manual wheelchairs, motorized wheelchairs, motor-assisted wheelchairs, and electric scooters)
Community-dwelling
Ability to independently move one or both upper extremities
Has participated in no more than 60 minutes of moderate-intensity physical activity per week in the past month
English-speaking
Able to provide informed consent
Willing to participate in two assessments and 40 intervention sessions

Exclusion Criteria:

Determination by their physician to be medically unstable
Has had cardiovascular complications within the past year or unstable heart disease
Currently receiving medical treatment for an acute injury
Presence of a stage IV pressure injury
Currently pregnant or suspect pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63108

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Kerri A Morgan, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kerri Morgan, Assistant Professor of Occupational Therapy and Neurology, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT06013046

Other Study ID Numbers:

202209017

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kerri Morgan, Assistant Professor of Occupational Therapy and Neurology, Washington University School of Medicine

Occupational Therapy

Exercise

Study Results

No Results Posted as of Aug 28, 2023