Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880966
Status:
RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-04-17
Brief Title:
Functional Fitness for Overweight or Obese Adults With Mobility Disabilities
Sponsor:
University of Kansas
Organization:
University of Kansas
Study Overview
Official Title:
Functional Training for OverweightObese Adults With Mobility-related Disabilities
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COBRE Pilot
Brief Summary:
Over 64 million people in the US have a permanent disability with mobility-related disability MRD representing the most prevalent disability type 137 Adults with MRD are 66 more likely to be overweight or obese than their non-disabled peers Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension hyperlipidemia insulin processingsensitivity etc However over half 57 of adults with MRD do not exercise while 22 engage in exercise of insufficient duration or intensity to obtain health benefits Adults with MRD face numerous barriers to participation in community-based exercise and exercise is frequently limited to short-term referrals for outpatient physical andor occupational therapy High-intensity functional training HIFT represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions in addition to improving physical function and aspects of psychosocial health for people with disabilities Preliminary evidence supports the effectiveness of HIFT to improve body composition cardiovascular and muscular fitness insulin processing and insulin sensitivity in non-disabled adults who are overweightobese To date no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweightobese adults with MRD Thus the proposed study will implement a 6-mo pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention 60 min sessions3 dayswk in 25 adults with MRD and overweightobesity
This study will address the following aims
Aim 1 Evaluate the intervention feasibility based on participant recruitment session attendance retention outcome assessment completion and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention
Aim 2 Evaluate changes baseline - 6 mos in weight and fat-massfat-free mass and components of the metabolic syndrome waist circumference blood pressure HDL-cholesterol triglycerides fasting glucose
This study will address the following aims
Aim 1 Evaluate the intervention feasibility based on participant recruitment session attendance retention outcome assessment completion and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention
Aim 2 Evaluate changes baseline - 6 mos in weight and fat-massfat-free mass and components of the metabolic syndrome waist circumference blood pressure HDL-cholesterol triglycerides fasting glucose
Detailed Description:
Over 64 million people in the US have a permanent disability with mobility-related disability MRD representing the most prevalent disability type 137 The occurrence of chronic conditions including obesity diabetes hypertension and hyperlipidemia are significantly higher in adults with disabilities compared with non-disabled adults Adults with MRD are 66 more likely to be overweight or obese than their non-disabled peers Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension hyperlipidemia insulin processingsensitivity etc However over half 57 of adults with MRD do not exercise while 22 engage in exercise of insufficient duration or intensity to obtain health benefits Adults with MRD face numerous intrapersonal environmental and financial barriers to participation in community-based exercise and exercise is frequently limited to short-term referrals for outpatient physical andor occupational therapy While effective these clinical settings do not provide a long-term strategy for the delivery of exercise programs to the general population of adults with MRD
High-intensity functional training HIFT represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions in addition to improving physical function and aspects of psychosocial health for people with disabilities HIFT incorporates multiple exercise modalities and constantly varied functional movement patterns designed to simulate daily activities eg sit-to-stand transferring The variety of functional movements offered by HIFT may be more enjoyable and result in better long-term adherence compared with traditional single mode continuous aerobic exercise such as stationary biking arm cycling or treadmill walkingrunning Preliminary evidence supports the effectiveness of HIFT to improve body composition cardiovascular and muscular fitness insulin processing and insulin sensitivity in non-disabled adults who are overweightobese The limited available data relative to HIFT interventions in adults with MRD provides some support for the feasibility and potential effectiveness of HIFT in adults with MRD including high retention rates positive intervention experiences improved functional capacity and confidence in performing daily movements However this data is based on unpowered pilot studies and unpublished thesedissertations with poor descriptions of the HIFT interventions and thus should be cautiously interpreted To date no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweightobese adults with MRD Thus Thus the proposed study will implement a 6-mo pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention 60 min sessions3 dayswk in 25 adults with MRD and overweightobesity The intervention will be conducted at two community-based facilities in greater Kansas City that have been conducting HIFT sessions for adults with disabilities for over three years HIFT sessions will be delivered by instructors certified by the Adaptive Training Academy ATA a non-profit organization which provides training in adapting and conducting safe HIFT sessions for people with disabilities This study will address the following aims
Aim 1 Evaluate the intervention feasibility based on participant recruitment session attendance retention outcome assessment completion and the results of semi-structured exit interviews to obtain information regarding study improvements perceptions of the lengthfrequency of the intervention satisfaction with instructors exercise facilities session content difficulties with compliance and overall satisfaction with the intervention
Aim 2 Evaluate changes baseline - 6 mos in weight primary outcome and secondary outcomes including fat-massfat-free mass and components of the metabolic syndrome waist circumference blood pressure HDL-cholesterol triglycerides fasting glucose Energy expenditure will also be measured during HIFT sessions using portable indirect calorimetry
Results from this study will inform the development of an NIH-R01 application to conduct an adequately powered randomized trial in overweightobese adults with MRD to evaluate the effectiveness of HIFT over a longer time frame ie 12 mos on the obesity-related outcomes proposed for this study plus additional health and functional related outcomes If ultimately shown to be effective the physical infrastructure available in the over 5000 HIFT affiliates across the country would provide the framework for widespread adoption implementation and maintenance of inclusive HIFT programs for adults with MRD
High-intensity functional training HIFT represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions in addition to improving physical function and aspects of psychosocial health for people with disabilities HIFT incorporates multiple exercise modalities and constantly varied functional movement patterns designed to simulate daily activities eg sit-to-stand transferring The variety of functional movements offered by HIFT may be more enjoyable and result in better long-term adherence compared with traditional single mode continuous aerobic exercise such as stationary biking arm cycling or treadmill walkingrunning Preliminary evidence supports the effectiveness of HIFT to improve body composition cardiovascular and muscular fitness insulin processing and insulin sensitivity in non-disabled adults who are overweightobese The limited available data relative to HIFT interventions in adults with MRD provides some support for the feasibility and potential effectiveness of HIFT in adults with MRD including high retention rates positive intervention experiences improved functional capacity and confidence in performing daily movements However this data is based on unpowered pilot studies and unpublished thesedissertations with poor descriptions of the HIFT interventions and thus should be cautiously interpreted To date no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweightobese adults with MRD Thus Thus the proposed study will implement a 6-mo pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention 60 min sessions3 dayswk in 25 adults with MRD and overweightobesity The intervention will be conducted at two community-based facilities in greater Kansas City that have been conducting HIFT sessions for adults with disabilities for over three years HIFT sessions will be delivered by instructors certified by the Adaptive Training Academy ATA a non-profit organization which provides training in adapting and conducting safe HIFT sessions for people with disabilities This study will address the following aims
Aim 1 Evaluate the intervention feasibility based on participant recruitment session attendance retention outcome assessment completion and the results of semi-structured exit interviews to obtain information regarding study improvements perceptions of the lengthfrequency of the intervention satisfaction with instructors exercise facilities session content difficulties with compliance and overall satisfaction with the intervention
Aim 2 Evaluate changes baseline - 6 mos in weight primary outcome and secondary outcomes including fat-massfat-free mass and components of the metabolic syndrome waist circumference blood pressure HDL-cholesterol triglycerides fasting glucose Energy expenditure will also be measured during HIFT sessions using portable indirect calorimetry
Results from this study will inform the development of an NIH-R01 application to conduct an adequately powered randomized trial in overweightobese adults with MRD to evaluate the effectiveness of HIFT over a longer time frame ie 12 mos on the obesity-related outcomes proposed for this study plus additional health and functional related outcomes If ultimately shown to be effective the physical infrastructure available in the over 5000 HIFT affiliates across the country would provide the framework for widespread adoption implementation and maintenance of inclusive HIFT programs for adults with MRD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None