Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304207
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-06-20
Brief Title:
Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease
Sponsor:
MGH Institute of Health Professions
Organization:
MGH Institute of Health Professions
Study Overview
Official Title:
Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
CLD
Brief Summary:
The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease
The specific aims of the study are
To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes dyspnea exercise capacity physical function physical activity and quality of life at 8 weeks and 4-months post-intervention
To compare the differences in dyspnea exercise capacity physical function physical activity and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation
Participants in both intervention groups onsite and tele-rehab will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting Control group will receive biweekly check in calls but no active intervention
The specific aims of the study are
To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes dyspnea exercise capacity physical function physical activity and quality of life at 8 weeks and 4-months post-intervention
To compare the differences in dyspnea exercise capacity physical function physical activity and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation
Participants in both intervention groups onsite and tele-rehab will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting Control group will receive biweekly check in calls but no active intervention
Detailed Description:
Random Assignment Participants will be randomly assigned using a web-based randomization service wwwrandomizenet to one of three groups 1 tele-rehab where patient will be at home but will receive supervised intervention remotely 2 onsite outpatient rehabilitation and 3 control group using a computerized random number generator to eliminate risk of bias during allocation
Subject Enrollment Consent Potential participants who express interest in the study will be contacted via a phone call by the study team to go over screening and to seek consent for the study Pre-screening questions will be asked over the phone to confirm eligibility The letter of informed consent will be read out during the initial phone call and participants will be asked to sign a copy of the consent form prior to their initial visit at the IMPACT Practice Center at MGH Institute of Health Professions via a RedCap link sent to their email Any questions related to the study will be answered prior to getting a signature on the consent form See attached consent form Participants will be informed of the possibility of being in one of three groups The study Investigators will be involved in obtaining consent Control group participants will be offered an opportunity to complete an 8-week onsite or tele-rehab intervention upon completion of the study duration Participants will be able to withdraw from the study at any point with no penalties or any negative consequences Participation will be voluntary and participants can choose to step out of the study at any time
To enhance enrollment of participants from diverse and under-represented backgrounds free parking will be provided to the onsite location at MGH Institute of Health Professions For participants assigned to the tele-rehab group who do not have the means to connect and participate in the intervention will be loaned an I-pad for the duration of the study In addition all participants will be provided with a 5000 gift card at the end of the study period for their participation in the study
6 STUDY PROCEDURES
Following informed consent all participants will undergo a baseline assessment at index date or time point 0 Since the recruitment will occur on a rolling basis the time 0 will vary for participants
Outcome Assessments time 0-time 2
All outcomes will be recorded at baseline prior to beginning of intervention time 0 at the end of the study intervention at 8 weeks time 1 and at 4 months follow-up time 2 post intervention Each participant n30 will start at time 0 with examination of outcome measurements at the IMPACT practice center at MGH IHP Outcomes will be assessed by a study team member who will be blinded to the group allocation Outcomes assessed will include the modified Medical Research Council mMRC scale and the dyspnea rating scale for dyspnea physical function measured by the 30 seconds chair rise test and the 10-meter walk test functional capacity measured by the six minute walk test physical activity measured by the International Physical Activity Questionnaire and quality of life measured by the COPD Assessment Test CAT and the PROMIS Global Health Scale Assessment of inspiratory muscle strength will be performed using the maximal inspiratory pressure gauge MIP In addition baseline vitals heart rate respiratory rate oxygen saturation SpO2 via pulse oximeter and rating of perceived exertion RPE scale at rest will be documented
The training intensity will be derived from the distance covered on the six-minute walk test Although participants completing the traditional onsite rehabilitation program at MGH are extensively educated and independent in self-monitoring their oxygen saturation through pulse oximetry RPE and heart rate these will be reviewed thoroughly during the initial visit with all participants In addition to these outcomes participants will be asked to report any planned or unplanned physician visits emergency room visits falls and injuries The number of sessions attended by participants will also be recorded
All participants will receive printed educational resources from the COPD Foundation and Pulmonary Fibrosis Foundation on 1 tips for living well with Chronic Lung Disease 2 Impact of smoking and 3 Chronic Lung Disease action plan including resources for disaster preparedness
Following assessment of outcomes at baseline participants will begin the 8-week intervention Supervised visits will occur once every week for both the onsite and tele-rehab groups
Interventions
Participants in both intervention groups onsite and tele-rehab will receive a 60-minute supervised weekly exercise intervention Interventions will be delivered by study team members that are licensed physical therapists or students under the supervision of these physical therapists The study personnel will be paid to provide the intervention and collect outcomes All participants will receive similar interventions as described in Table 1 The interventions received will be similar to standard clinical sessions however participants andor their insurers will not be charged for either the on-site or the telehealth interventions
Each 60-minute session will be broken down into separate sections These include a brief 5-minute training on inspiratory muscle training using a Threshold Inspiratory Muscle Trainer IMT Respironics Threshold PEP and 5-minute check-in a review of their activities during the week at home and any changes in symptoms as well as education on self-management of airway clearance and importance of maintaining regular physical activity This will be followed by a 5-minute warm-up and 25 minutes of aerobic training in the form of walking cycling stair climbing or NuStep based on availability and patient preference The training intensity will be derived from the distance covered on the six-minute walk test administered at baseline Peak oxygen consumption VO2 will be estimated based on previously published regression equations Training will be performed at 60-85 of VO2 reserve and converted to walking distance and speed using American College of Sports Medicine walking equations for treadmill and overground walking activities or a corresponding rating of perceived exertion RPE of 13-16 for non-walking activities cycling stair climbing Aerobic training may be completed in shorter intervals if continuous training is limited by symptoms eg 2 125 minutes or 3 83 minutes This will be followed by 15-minutes of functional strength training focusing on the lower extremity muscles such as partial squats sit to stand exercise lunges and step ups and downs
Progression of exercise will occur each week as increase in walking or stair climbing speed increase in wattage of cycle ergometer and NuStep by 5-10 while maintaining dyspnea levels of 3-410 on the dyspnea rating scale and maintaining an RPE of 13-16 Functional strengthening exercises will be progressed by increasing number repetitions while maintaining the dyspnea rating scale at 3-410 Inspiratory muscle training will progress by 5 each week to maintain dyspnea levels of 3-410 on the dyspnea rating scale If the progression in any of the components elicits dyspnea more than 4 the same training intensity will be continued for another week
All participants will be encouraged to maintain a log of activities performed during the week
Tele-rehab group
Participants in the tele-rehab group will also receive the same intervention as outlined for the onsite group The mode of aerobic exercise will vary based on availability see table 1 The intervention will be delivered remotely via previously researched models using a tablet computer I-pads will be provided to the participants on a need basis to take home for the duration of the study Videoconferencing will be via Partners log in enabled Zoom videoconferencing software San Jose California USA that allows all participants to see and speak to each other To ensure safety and understanding of equipment operation and the exercise program the initial training session and establishment of the home exercise program will occur during the initial onsite visit in the clinic at MGH Institute of Health Professions
Although participants completing the traditional onsite rehabilitation program are familiar with and educated on independent in self-monitoring their SpO2 RPE and heart rate these will be reviewed during the initial visit with all participants Pulse oximeters will be provided to participants for the duration of the study
Fidelity of the exercise training intervention for both groups will be facilitated through regular staff training and audit of exercise prescription and progression and assessment of participant engagement
Control group Control group participants will only be seen during the outcomes assessments at the MGH Institute of Health Professions at times 0 1 and 2 but will receive no active supervised intervention Control group participants will go home with discharge instructions to maintain a home exercise routine provided to them at discharge Bi-weekly check in phone calls from the study team will continue to ensure participant engagement in the study During the phone calls participants will be encouraged to keep a log of their weekly activities in a journal
Data Collection The data that is collected from each patient will include participant demographics age sex comorbidities body mass index race education work status living situation living alone or with partnercaregiver in independent home or institutionalized details of interventions provided each visit log of activities performed during the week outcome measures and the number of sessions attended along with any planned or unplanned physician visits emergency room visits hospitalizations falls and injuries
Termination Criteria If a participant is to experience an adverse event during the course of the study they will be terminated from the study until they receive medical clearance Adverse events include any falls with or without injury hospitalizations or unplanned visits to their physician for Chronic Lung Disease related symptoms If patient is unable to return to the study any data collected up until time of adverse event will be included in study and the adverse event will be noted Any adverse events will be reported to the IRB If patient is allowed to return to regular exercise the event will still be noted and reported Any changes in medication or medical status will be monitored
Remuneration All participants will be given 5000 in total at the end of the study
Subject Enrollment Consent Potential participants who express interest in the study will be contacted via a phone call by the study team to go over screening and to seek consent for the study Pre-screening questions will be asked over the phone to confirm eligibility The letter of informed consent will be read out during the initial phone call and participants will be asked to sign a copy of the consent form prior to their initial visit at the IMPACT Practice Center at MGH Institute of Health Professions via a RedCap link sent to their email Any questions related to the study will be answered prior to getting a signature on the consent form See attached consent form Participants will be informed of the possibility of being in one of three groups The study Investigators will be involved in obtaining consent Control group participants will be offered an opportunity to complete an 8-week onsite or tele-rehab intervention upon completion of the study duration Participants will be able to withdraw from the study at any point with no penalties or any negative consequences Participation will be voluntary and participants can choose to step out of the study at any time
To enhance enrollment of participants from diverse and under-represented backgrounds free parking will be provided to the onsite location at MGH Institute of Health Professions For participants assigned to the tele-rehab group who do not have the means to connect and participate in the intervention will be loaned an I-pad for the duration of the study In addition all participants will be provided with a 5000 gift card at the end of the study period for their participation in the study
6 STUDY PROCEDURES
Following informed consent all participants will undergo a baseline assessment at index date or time point 0 Since the recruitment will occur on a rolling basis the time 0 will vary for participants
Outcome Assessments time 0-time 2
All outcomes will be recorded at baseline prior to beginning of intervention time 0 at the end of the study intervention at 8 weeks time 1 and at 4 months follow-up time 2 post intervention Each participant n30 will start at time 0 with examination of outcome measurements at the IMPACT practice center at MGH IHP Outcomes will be assessed by a study team member who will be blinded to the group allocation Outcomes assessed will include the modified Medical Research Council mMRC scale and the dyspnea rating scale for dyspnea physical function measured by the 30 seconds chair rise test and the 10-meter walk test functional capacity measured by the six minute walk test physical activity measured by the International Physical Activity Questionnaire and quality of life measured by the COPD Assessment Test CAT and the PROMIS Global Health Scale Assessment of inspiratory muscle strength will be performed using the maximal inspiratory pressure gauge MIP In addition baseline vitals heart rate respiratory rate oxygen saturation SpO2 via pulse oximeter and rating of perceived exertion RPE scale at rest will be documented
The training intensity will be derived from the distance covered on the six-minute walk test Although participants completing the traditional onsite rehabilitation program at MGH are extensively educated and independent in self-monitoring their oxygen saturation through pulse oximetry RPE and heart rate these will be reviewed thoroughly during the initial visit with all participants In addition to these outcomes participants will be asked to report any planned or unplanned physician visits emergency room visits falls and injuries The number of sessions attended by participants will also be recorded
All participants will receive printed educational resources from the COPD Foundation and Pulmonary Fibrosis Foundation on 1 tips for living well with Chronic Lung Disease 2 Impact of smoking and 3 Chronic Lung Disease action plan including resources for disaster preparedness
Following assessment of outcomes at baseline participants will begin the 8-week intervention Supervised visits will occur once every week for both the onsite and tele-rehab groups
Interventions
Participants in both intervention groups onsite and tele-rehab will receive a 60-minute supervised weekly exercise intervention Interventions will be delivered by study team members that are licensed physical therapists or students under the supervision of these physical therapists The study personnel will be paid to provide the intervention and collect outcomes All participants will receive similar interventions as described in Table 1 The interventions received will be similar to standard clinical sessions however participants andor their insurers will not be charged for either the on-site or the telehealth interventions
Each 60-minute session will be broken down into separate sections These include a brief 5-minute training on inspiratory muscle training using a Threshold Inspiratory Muscle Trainer IMT Respironics Threshold PEP and 5-minute check-in a review of their activities during the week at home and any changes in symptoms as well as education on self-management of airway clearance and importance of maintaining regular physical activity This will be followed by a 5-minute warm-up and 25 minutes of aerobic training in the form of walking cycling stair climbing or NuStep based on availability and patient preference The training intensity will be derived from the distance covered on the six-minute walk test administered at baseline Peak oxygen consumption VO2 will be estimated based on previously published regression equations Training will be performed at 60-85 of VO2 reserve and converted to walking distance and speed using American College of Sports Medicine walking equations for treadmill and overground walking activities or a corresponding rating of perceived exertion RPE of 13-16 for non-walking activities cycling stair climbing Aerobic training may be completed in shorter intervals if continuous training is limited by symptoms eg 2 125 minutes or 3 83 minutes This will be followed by 15-minutes of functional strength training focusing on the lower extremity muscles such as partial squats sit to stand exercise lunges and step ups and downs
Progression of exercise will occur each week as increase in walking or stair climbing speed increase in wattage of cycle ergometer and NuStep by 5-10 while maintaining dyspnea levels of 3-410 on the dyspnea rating scale and maintaining an RPE of 13-16 Functional strengthening exercises will be progressed by increasing number repetitions while maintaining the dyspnea rating scale at 3-410 Inspiratory muscle training will progress by 5 each week to maintain dyspnea levels of 3-410 on the dyspnea rating scale If the progression in any of the components elicits dyspnea more than 4 the same training intensity will be continued for another week
All participants will be encouraged to maintain a log of activities performed during the week
Tele-rehab group
Participants in the tele-rehab group will also receive the same intervention as outlined for the onsite group The mode of aerobic exercise will vary based on availability see table 1 The intervention will be delivered remotely via previously researched models using a tablet computer I-pads will be provided to the participants on a need basis to take home for the duration of the study Videoconferencing will be via Partners log in enabled Zoom videoconferencing software San Jose California USA that allows all participants to see and speak to each other To ensure safety and understanding of equipment operation and the exercise program the initial training session and establishment of the home exercise program will occur during the initial onsite visit in the clinic at MGH Institute of Health Professions
Although participants completing the traditional onsite rehabilitation program are familiar with and educated on independent in self-monitoring their SpO2 RPE and heart rate these will be reviewed during the initial visit with all participants Pulse oximeters will be provided to participants for the duration of the study
Fidelity of the exercise training intervention for both groups will be facilitated through regular staff training and audit of exercise prescription and progression and assessment of participant engagement
Control group Control group participants will only be seen during the outcomes assessments at the MGH Institute of Health Professions at times 0 1 and 2 but will receive no active supervised intervention Control group participants will go home with discharge instructions to maintain a home exercise routine provided to them at discharge Bi-weekly check in phone calls from the study team will continue to ensure participant engagement in the study During the phone calls participants will be encouraged to keep a log of their weekly activities in a journal
Data Collection The data that is collected from each patient will include participant demographics age sex comorbidities body mass index race education work status living situation living alone or with partnercaregiver in independent home or institutionalized details of interventions provided each visit log of activities performed during the week outcome measures and the number of sessions attended along with any planned or unplanned physician visits emergency room visits hospitalizations falls and injuries
Termination Criteria If a participant is to experience an adverse event during the course of the study they will be terminated from the study until they receive medical clearance Adverse events include any falls with or without injury hospitalizations or unplanned visits to their physician for Chronic Lung Disease related symptoms If patient is unable to return to the study any data collected up until time of adverse event will be included in study and the adverse event will be noted Any adverse events will be reported to the IRB If patient is allowed to return to regular exercise the event will still be noted and reported Any changes in medication or medical status will be monitored
Remuneration All participants will be given 5000 in total at the end of the study
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