Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01783704
Status:
COMPLETED
Last Update Posted:
2022-01-27
First Post:
2013-01-31
Brief Title:
Improving Community Ambulation After Hip Fracture
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Improving Community Ambulation After Hip Fracture
Status:
COMPLETED
Status Verified Date:
2022-01
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:
CAP
Brief Summary:
Activity and exercise are believed to be of benefit for reducing disability in older adults yet the majority of older adults do not participate in regular exercise and is not active This is especially true for older adults following hip fracture after they complete the usual rehabilitation program
This study is being done to compare two 16-week supervised multi-part physical therapy programs interventions initiated up to 26 weeks after hip fracture The investigators want to test whether the interventions lead to improvements in a persons ability to walk on their own in the home and in the local community With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health
ANCILLARY STUDY 1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION CAP-MP The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland Baltimore UMB clinical site of CAP
ANCILLARY STUDY 2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture The identified dietary patterns as well as motivators and barriers to intake will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center UCHC clinical site of CAP
ANCILLARY STUDY 3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP
ANCILLARY STUDY 4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University AU clinical site of CAP
This study is being done to compare two 16-week supervised multi-part physical therapy programs interventions initiated up to 26 weeks after hip fracture The investigators want to test whether the interventions lead to improvements in a persons ability to walk on their own in the home and in the local community With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health
ANCILLARY STUDY 1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION CAP-MP The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland Baltimore UMB clinical site of CAP
ANCILLARY STUDY 2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture The identified dietary patterns as well as motivators and barriers to intake will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center UCHC clinical site of CAP
ANCILLARY STUDY 3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP
ANCILLARY STUDY 4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University AU clinical site of CAP
Detailed Description:
MAIN STUDY
Despite improvements in medical management significant residual disability remains in older persons after a hip fracture The goal of current clinical practice is independent safe household ambulation two to three months after surgery Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation ie usual care fails to return many patients to pre-fracture levels of function In contrast to stroke and heart disease other commonly occurring acute conditions in the older population there are few intervention trials focused on decreasing disability following hip fracture None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community ie community ambulation Thus there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community rather than merely household ambulation
A randomized controlled trial RCT including 210 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention PUSH and the other half receiving a non-specific multi-component intervention PULSE Randomization of 210 participants meeting eligibility criteria will take place after post-acute rehabilitation ends approximately 6 months 26 weeks after admission to the hospital for hip fracture The primary endpoint will be measured using the Six-Minute Walk Test SMWT at the end of the 16-week intervention period The goal is to enable older adults who have experienced a hip fracture to recover sufficiently to become community ambulators
Primary Aim The primary aim of the study is to determine if a specific multi-component 16-week intervention based on aerobic conditioning specificity of training and muscle overload the PUSH intervention initiated within 26 weeks of admission to the hospital for hip fracture will be more successful in producing community ambulation at 16 weeks after randomization than a non-specific multi-component intervention of transcutaneous electrical nerve stimulation TENS flexibility activities and active range of motion exercises AROM the PULSE intervention
Secondary Aims
1 To determine whether the proportion of community ambulators differs between the PUSH and PULSE interventions at 40 weeks post-randomization and whether the difference in proportions at 40 weeks changed from the difference in proportions at 16 weeks
2 To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to five secondary outcomes that are thought to be precursors to community ambulation endurance dynamic balance walking speed quadriceps strength and lower extremity function
3 To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to several tertiary outcomes activities of daily living quality of life physical activity lower extremity physical performance balance confidence increase of 50 meters or more in distance walked in six minutes nutritional status cognitive status and depressive symptoms
4 To compare the economic value of the PUSH and PULSE interventions by estimating the impact of the interventions on cost per quality-adjusted life year QALY gained over the follow-up period
In addition to study outcome measures expected adverse events AEs will be assessed every four weeks during a telephone interview Information about reportable adverse events RAEs which include serious adverse events SAEs unexpected AEs or injury that occurs under supervision by study staff will be collected throughout the study Vitamin D calcium and multivitamin adherence will be monitored by pill counts every four weeks during the intervention period and by self-report during the 4-week telephone calls Adherence with the PT interventions will also be monitored
For participants randomized prior to version 100 of the protocol follow-up assessment visits occurred 16 weeks and 40 weeks from the date of randomization and telephone interviews were conducted every four weeks during the 40-week study period for a total of 10 telephone interviews For participants consented under version 100 of the protocol all follow-up will end at 16 weeks post-randomization In version 110 of the protocol we will eliminate several secondary and tertiary outcome measures In the description of outcome measures we identify the measures that will not be collected for participants consented under protocol version 110 or later
ANCILLARY STUDIES
ANCILLARY STUDY 1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION CAP-MP - Dr Jay Magaziner Ancillary Study 1 Start Date April 12 2014 Primary Completion Date October 19 2017 n39 The CAP-MP ancillary study is intended to supplement the information gained from the parent CAP study to help investigators understand how older adults recover after injury Participants enrolled in the CAP parent study at the Baltimore site are invited to participate in the CAP-MP ancillary study and undergo additional testing at the same time points as for the parent CAP study The objective of the CAP-MP ancillary study is to examine mechanistic factors hypothesized to be on the pathway between two 16-week interventions post-hip fracture and recovery and the ability to ambulate independently in the community The effect of the interventions on these factors 24 weeks after the intervention ends also will be evaluated The outcomes for the CAP-MP ancillary study are secondary or tertiary to the main CAP study
Primary Aim To determine if at the end of the 16-week intervention participants in the PUSH group compared to the PULSE group have a greater muscle volume and attenuation ie reduced intra-muscular fat of the thigh b greater lower extremity strength c greater bone mineral density and bone strength d more bone formation and less bone resorption e lower levels of circulating inflammatory cytokines f higher levels of the hormones insulin-like growth factor IGF-1 testosterone and estradiol g greater aerobic capacity h greater improvement in gait and balance and i better cognition and fewer depressive symptoms
Secondary Aim 1 To determine the long-term ie 24 weeks after intervention ends effect of the intervention on the mechanistic factors detailed in the primary aim
Secondary Aim 2 To evaluate the relationships between mechanistic factors detailed in the primary aim above and community ambulatory ability at the end of the intervention and 24 weeks later in order to identify those mechanisms that are most responsible for the ability to ambulate in the community following delivery of the intervention
Tertiary Aim To quantify the mediating effect of mechanistic factors detailed in the primary aim on the relationship between the intervention and ability to ambulate in the community at the end of the intervention 16 weeks post-randomization and 24 weeks later
ANCILLARY STUDY 2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION - Dr Anne Kenny n11 This ancillary study will analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture The identified dietary patterns as well as motivators and barriers to intake will be assessed for their impact on the rate of return to community ambulation in the CAP study
Hypothesis Those who consume dietary patterns similar to a Mediterranean style diet will have less malnutrition with greater likelihood for a return to community ambulation
Aim 1 At baseline determine degree of Mediterranean style diet intake and dietary patterns in our sample of hip fracture patients to correlate with nutritional status assessed by the Mini Nutritional Assessment tool MNA
Aim 2 Determine motivators and barriers to intake in the hip fracture rehabilitation population and associate with dietary patterns and nutritional status
Aim 3 Diets determined at baseline will be used to predict community ambulation and similar primary endpoints for CAP
ANCILLARY STUDY 3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE - Dr Anne Kenny n21 The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in the population Data on rehabilitation capacity post-fracture in those with diabetes mellitus DM are limited and mixed Studies focusing on rehabilitation potential in DM demonstrate either no impact or a decrease in functional recovery
Hypothesis Community-dwelling ambulatory hip fracture survivors with impaired glucose metabolism measured as homeostasis model assessment-estimated insulin resistance HOMA- IR or diagnosis of DM will not recover lower extremity strength or function as well as those with normal glucose metabolism in response to resistance exercise compared to non-resistance training Further investigators propose that higher AGE measured as pentosidine level and its receptor will impair strength and functional improvement with resistance exercise Those with IR and DM have lower IGF-1 and higher levels of IGF binding proteins IGFBP1 and 3 further limiting the available IGF-1 for tissue use Investigators hypothesize that the strength and functional improvement from resistance exercise will be mitigated by higher IGFBP in those with DM and IR compared to those with normal glucose metabolism
Aim 1 To compare change in strength and function between those with diabetes mellitus insulin resistance or without either condition compared between two multi-component exercise interventions in which one includes resistance
Aim 2 To determine association between baseline AGE and IGFIGFBP on strength and functional improvement and evaluate contribution of change in biomarkers to musclefunction response from resistance exercise
ANCILLARY STUDY 4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE - Dr Marty Eastlack Ancillary Study 4 Start Date April 6 2015 Primary Completion Date December 13 2017 n22 The purpose of this ancillary study is therefore to examine the effect of the two interventions on the precursors to participation in the community
Hypothesis Those who participate in the PUSH intervention will have less impairment in body structure and function muscle thickness and echo intensity fewer limitations in activities chair rate of rise and fast gait speed and therefore better likelihood to return to participation community ambulation
Aim 1 To determine if there is a difference between PUSH and PULSE with respect to change in muscle quality muscle thickness and echo intensity muscle power chair rate of rise and fast gait speed
Aim 2 To see if differences persist 40 weeks post-randomization Aim 3 To see if changes in muscle quality predict faster gait speed chair rate of rise and chair rise strategy this is categorical among all participants
Aim 4 To describe the quality of movement chair rise strategy and capacity standing symmetry temporospatial aspects of gait among all participants
Aim 5 To confirm that rate of rise in standing is a proxy for instrumented measure of lower extremity power
Despite improvements in medical management significant residual disability remains in older persons after a hip fracture The goal of current clinical practice is independent safe household ambulation two to three months after surgery Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation ie usual care fails to return many patients to pre-fracture levels of function In contrast to stroke and heart disease other commonly occurring acute conditions in the older population there are few intervention trials focused on decreasing disability following hip fracture None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community ie community ambulation Thus there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community rather than merely household ambulation
A randomized controlled trial RCT including 210 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention PUSH and the other half receiving a non-specific multi-component intervention PULSE Randomization of 210 participants meeting eligibility criteria will take place after post-acute rehabilitation ends approximately 6 months 26 weeks after admission to the hospital for hip fracture The primary endpoint will be measured using the Six-Minute Walk Test SMWT at the end of the 16-week intervention period The goal is to enable older adults who have experienced a hip fracture to recover sufficiently to become community ambulators
Primary Aim The primary aim of the study is to determine if a specific multi-component 16-week intervention based on aerobic conditioning specificity of training and muscle overload the PUSH intervention initiated within 26 weeks of admission to the hospital for hip fracture will be more successful in producing community ambulation at 16 weeks after randomization than a non-specific multi-component intervention of transcutaneous electrical nerve stimulation TENS flexibility activities and active range of motion exercises AROM the PULSE intervention
Secondary Aims
1 To determine whether the proportion of community ambulators differs between the PUSH and PULSE interventions at 40 weeks post-randomization and whether the difference in proportions at 40 weeks changed from the difference in proportions at 16 weeks
2 To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to five secondary outcomes that are thought to be precursors to community ambulation endurance dynamic balance walking speed quadriceps strength and lower extremity function
3 To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to several tertiary outcomes activities of daily living quality of life physical activity lower extremity physical performance balance confidence increase of 50 meters or more in distance walked in six minutes nutritional status cognitive status and depressive symptoms
4 To compare the economic value of the PUSH and PULSE interventions by estimating the impact of the interventions on cost per quality-adjusted life year QALY gained over the follow-up period
In addition to study outcome measures expected adverse events AEs will be assessed every four weeks during a telephone interview Information about reportable adverse events RAEs which include serious adverse events SAEs unexpected AEs or injury that occurs under supervision by study staff will be collected throughout the study Vitamin D calcium and multivitamin adherence will be monitored by pill counts every four weeks during the intervention period and by self-report during the 4-week telephone calls Adherence with the PT interventions will also be monitored
For participants randomized prior to version 100 of the protocol follow-up assessment visits occurred 16 weeks and 40 weeks from the date of randomization and telephone interviews were conducted every four weeks during the 40-week study period for a total of 10 telephone interviews For participants consented under version 100 of the protocol all follow-up will end at 16 weeks post-randomization In version 110 of the protocol we will eliminate several secondary and tertiary outcome measures In the description of outcome measures we identify the measures that will not be collected for participants consented under protocol version 110 or later
ANCILLARY STUDIES
ANCILLARY STUDY 1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION CAP-MP - Dr Jay Magaziner Ancillary Study 1 Start Date April 12 2014 Primary Completion Date October 19 2017 n39 The CAP-MP ancillary study is intended to supplement the information gained from the parent CAP study to help investigators understand how older adults recover after injury Participants enrolled in the CAP parent study at the Baltimore site are invited to participate in the CAP-MP ancillary study and undergo additional testing at the same time points as for the parent CAP study The objective of the CAP-MP ancillary study is to examine mechanistic factors hypothesized to be on the pathway between two 16-week interventions post-hip fracture and recovery and the ability to ambulate independently in the community The effect of the interventions on these factors 24 weeks after the intervention ends also will be evaluated The outcomes for the CAP-MP ancillary study are secondary or tertiary to the main CAP study
Primary Aim To determine if at the end of the 16-week intervention participants in the PUSH group compared to the PULSE group have a greater muscle volume and attenuation ie reduced intra-muscular fat of the thigh b greater lower extremity strength c greater bone mineral density and bone strength d more bone formation and less bone resorption e lower levels of circulating inflammatory cytokines f higher levels of the hormones insulin-like growth factor IGF-1 testosterone and estradiol g greater aerobic capacity h greater improvement in gait and balance and i better cognition and fewer depressive symptoms
Secondary Aim 1 To determine the long-term ie 24 weeks after intervention ends effect of the intervention on the mechanistic factors detailed in the primary aim
Secondary Aim 2 To evaluate the relationships between mechanistic factors detailed in the primary aim above and community ambulatory ability at the end of the intervention and 24 weeks later in order to identify those mechanisms that are most responsible for the ability to ambulate in the community following delivery of the intervention
Tertiary Aim To quantify the mediating effect of mechanistic factors detailed in the primary aim on the relationship between the intervention and ability to ambulate in the community at the end of the intervention 16 weeks post-randomization and 24 weeks later
ANCILLARY STUDY 2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION - Dr Anne Kenny n11 This ancillary study will analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture The identified dietary patterns as well as motivators and barriers to intake will be assessed for their impact on the rate of return to community ambulation in the CAP study
Hypothesis Those who consume dietary patterns similar to a Mediterranean style diet will have less malnutrition with greater likelihood for a return to community ambulation
Aim 1 At baseline determine degree of Mediterranean style diet intake and dietary patterns in our sample of hip fracture patients to correlate with nutritional status assessed by the Mini Nutritional Assessment tool MNA
Aim 2 Determine motivators and barriers to intake in the hip fracture rehabilitation population and associate with dietary patterns and nutritional status
Aim 3 Diets determined at baseline will be used to predict community ambulation and similar primary endpoints for CAP
ANCILLARY STUDY 3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE - Dr Anne Kenny n21 The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in the population Data on rehabilitation capacity post-fracture in those with diabetes mellitus DM are limited and mixed Studies focusing on rehabilitation potential in DM demonstrate either no impact or a decrease in functional recovery
Hypothesis Community-dwelling ambulatory hip fracture survivors with impaired glucose metabolism measured as homeostasis model assessment-estimated insulin resistance HOMA- IR or diagnosis of DM will not recover lower extremity strength or function as well as those with normal glucose metabolism in response to resistance exercise compared to non-resistance training Further investigators propose that higher AGE measured as pentosidine level and its receptor will impair strength and functional improvement with resistance exercise Those with IR and DM have lower IGF-1 and higher levels of IGF binding proteins IGFBP1 and 3 further limiting the available IGF-1 for tissue use Investigators hypothesize that the strength and functional improvement from resistance exercise will be mitigated by higher IGFBP in those with DM and IR compared to those with normal glucose metabolism
Aim 1 To compare change in strength and function between those with diabetes mellitus insulin resistance or without either condition compared between two multi-component exercise interventions in which one includes resistance
Aim 2 To determine association between baseline AGE and IGFIGFBP on strength and functional improvement and evaluate contribution of change in biomarkers to musclefunction response from resistance exercise
ANCILLARY STUDY 4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE - Dr Marty Eastlack Ancillary Study 4 Start Date April 6 2015 Primary Completion Date December 13 2017 n22 The purpose of this ancillary study is therefore to examine the effect of the two interventions on the precursors to participation in the community
Hypothesis Those who participate in the PUSH intervention will have less impairment in body structure and function muscle thickness and echo intensity fewer limitations in activities chair rate of rise and fast gait speed and therefore better likelihood to return to participation community ambulation
Aim 1 To determine if there is a difference between PUSH and PULSE with respect to change in muscle quality muscle thickness and echo intensity muscle power chair rate of rise and fast gait speed
Aim 2 To see if differences persist 40 weeks post-randomization Aim 3 To see if changes in muscle quality predict faster gait speed chair rate of rise and chair rise strategy this is categorical among all participants
Aim 4 To describe the quality of movement chair rise strategy and capacity standing symmetry temporospatial aspects of gait among all participants
Aim 5 To confirm that rate of rise in standing is a proxy for instrumented measure of lower extremity power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG035009-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AG035009-01A1 |