Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation (HH)

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee; Insomnia; Osteoarthritis, Hip
• Intervention / Treatment: Behavioral: Healthy Habits; Behavioral: Sleep Habits

Detailed Description

Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
    • Houston, Texas, United States, 77054
      • Kelsey Seybold Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.
2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
5. Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria:

1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Habits; This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.	Behavioral: Healthy Habits; Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.
Other: Sleep Habits; This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.	Behavioral: Sleep Habits; Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.	7-14 days before scheduled surgery
Insomnia Severity Index (ISI)	ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.	7-14 days after hospital discharge
Insomnia Severity Index (ISI)	ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.	7-14 days after completing the 8 week intervention period
Insomnia Severity Index (ISI)	ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.	6 months after completing the intervention
Wrist actigraphy	A wearable device will be used to measure participant sleep over seven days.	7-14 days before scheduled surgery
Wrist actigraphy	A wearable device will be used to measure participant sleep over seven days.	7-14 days after hospital discharge
Wrist actigraphy	A wearable device will be used to measure participant sleep over seven days.	7-14 days after completing the 8 week intervention period
Wrist actigraphy	A wearable device will be used to measure participant sleep over seven days.	6 months after completing the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Physical Function (short form)	The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'	7-14 days before scheduled surgery
PROMIS Physical Function (short form)	The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'	7-14 days after hospital discharge
PROMIS Physical Function (short form)	The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'	7-14 days after completing the 8 week intervention period
PROMIS Physical Function (short form)	The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'	6 months after completing the intervention
PROMIS Mobility	The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.	7-14 days before scheduled surgery
PROMIS Mobility	The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.	7-14 days after hospital discharge
PROMIS Mobility	The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.	7-14 days after completing the 8 week intervention period
PROMIS Mobility	The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.	6 months after completing the intervention
Short Physical Performance Battery (SPPB ) motor	The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.	7-14 days before scheduled surgery
Short Physical Performance Battery (SPPB ) motor	The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.	7-14 days after hospital discharge
Short Physical Performance Battery (SPPB ) motor	The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.	7-14 days after completing the 8 week intervention period
Short Physical Performance Battery (SPPB ) motor	The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.	6 months after completing the intervention
PROMIS Applied Cognitive Abilities	The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.	7-14 days before scheduled surgery
PROMIS Applied Cognitive Abilities	The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.	7-14 days after hospital discharge
PROMIS Applied Cognitive Abilities	The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.	7-14 days after completing the 8 week intervention period
PROMIS Applied Cognitive Abilities	The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.	6 months after completing the intervention
PROMIS Applied Cognitive Abilities- General Concerns	The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.	7-14 days before scheduled surgery
PROMIS Applied Cognitive Abilities- General Concerns	The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.	7-14 days after hospital discharge
PROMIS Applied Cognitive Abilities- General Concerns	The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.	7-14 days after completing the 8 week intervention period
PROMIS Applied Cognitive Abilities - General Concerns	The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.	6 months after completing the intervention
Tele-neuropsychology (T-NP) Battery	The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored.	7-14 days before scheduled surgery
Tele-neuropsychology (T-NP) Battery	The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.	7-14 days after hospital discharge
Tele-neuropsychology (T-NP) Battery	The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.	7-14 days after completing the 8 week intervention period
Tele-neuropsychology (T-NP) Battery	The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.	6 months after completing the intervention
Activities of Daily Living (ADLs)	The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"	7-14 days before scheduled surgery
Activities of Daily Living (ADLs)	The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"	7-14 days after hospital discharge
Activities of Daily Living (ADLs)	The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"	7-14 days after completing the 8 week intervention period
Activities of Daily Living (ADLs)	The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"	6 months after completing the intervention
Instrumental ADLs (IADL) scale	The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.	7-14 days before scheduled surgery
Instrumental ADLs (IADL) scale	The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.	7-14 days after hospital discharge
Instrumental ADLs (IADL) scale	The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.	7-14 days after completing the 8 week intervention period and
Instrumental ADLs (IADL) scale	The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.	6 months after completing the intervention
Sleep Diary	The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.	7-14 days before scheduled surgery
Sleep Diary	The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.	7-14 days after hospital discharge
Sleep Diary	The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.	During the 8 week intervention
Sleep Diary	The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.	7-14 days after completing the 8 week intervention period
Sleep Diary	The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.	6 months after completing the intervention
Knee injury and osteoarthritis outcome score (KOOS)	This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.	7-14 days before scheduled surgery
Knee injury and osteoarthritis outcome score (KOOS)	This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.	6 months after completing intervention
Hip disability and osteoarthritis outcome score (HOOS)	This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.	7-14 days before scheduled surgery
Hip disability and osteoarthritis outcome score (HOOS)	This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.	6 months after completing intervention
StepWatch	A wearable device will measure physical activity over a seven day period.	7-14 days before scheduled surgery
StepWatch	A wearable device will measure physical activity over a seven day period.	7-14 days after hospital discharge
StepWatch	A wearable device will measure physical activity over a seven day period.	7-14 days after completing the 8 week intervention period
StepWatch	A wearable device will measure physical activity over a seven day period.	6 months after completing the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain Intensity	The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.	7-14 days before scheduled surgery
PROMIS Pain Intensity	The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.	7-14 days after hospital discharge
PROMIS Pain Intensity	The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.	7-14 days after completing the 8 week intervention period
PROMIS Pain Intensity	The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.	6 months after completing the intervention
PROMIS Pain Interference	The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.	7-14 days before schedule surgery
PROMIS Pain Interference	The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.	7-14 days after hospital discharge
PROMIS Pain Interference	The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.	7-14 days after completing the 8 week intervention period
PROMIS Pain Interference	The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.	6 months after completing the intervention
PROMIS Fatigue	The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.	7-14 days before scheduled surgery
PROMIS Fatigue	The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.	7-14 days after hospital discharge
PROMIS Fatigue	The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.	7-14 days after completing the 8 week intervention period
PROMIS Fatigue	The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.	6 months after completing the intervention
PROMIS Emotional Distress-Depressesion	The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.	7-14 days before scheduled surgery
PROMIS Emotional Distress-Depressesion	The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.	7-14 days after hospital discharge
PROMIS Emotional Distress-Depressesion	The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.	7-14 days after completing the 8 week intervention period
PROMIS Emotional Distress-Depressesion	The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.	6 months after completing the intervention
PROMIS Psychosocial Illness Impact - Negative	The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.	7-14 days before scheduled surgery
PROMIS Psychosocial Illness Impact - Negative	The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after hospital discharge
PROMIS Psychosocial Illness Impact - Negative	The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after completing the 8 week intervention period
PROMIS Psychosocial Illness Impact - Negative	The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.	6 months after completing the intervention
PROMIS Satisfaction with Social Roles and Activities	The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.	7-14 days before scheduled surgery
PROMIS Satisfaction with Social Roles and Activities	The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after hospital discharge
PROMIS Satisfaction with Social Roles and Activities	The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after completing the 8 week intervention period
PROMIS Satisfaction with Social Roles and Activities	The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.	6 months after completing the intervention
PROMIS Ability to Participate in Social Roles and Activity	The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.	7-14 days before scheduled surgery
PROMIS Ability to Participate in Social Roles and Activity	The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after hospital discharge
PROMIS Ability to Participate in Social Roles and Activity	The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.	7-14 days after completing the 8 week intervention period
PROMIS Ability to Participate in Social Roles and Activity	The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.	6 months after completing the intervention
Rehabilitation Attendance	Weekly rehabilitation attendance will be measured via patient self-report.	From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks.
Plasma IL-6	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).	7-14 days before scheduled surgery
Plasma IL-6	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).	7-14 days after hospital discharge
Plasma IL-6	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).	7-14 days after completing the 8 week intervention period
Plasma IL-6	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).	6 months after completing the intervention
Plasma CRP	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)	7-14 days before scheduled surgery
Plasma CRP	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)	7-14 days after hospital discharge
Plasma CRP	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)	7-14 days after completing the 8 week intervention period
Plasma CRP	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)	6 months after completing the intervention
Plasma VWF	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)	7-14 days before scheduled surgery
Plasma VWF	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)	7-14 days after hospital discharge
Plasma VWF	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)	7-14 days after completing the 8 week intervention period
Plasma VWF	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)	6 months after completing the intervention
Plasma TNFalpha	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)	7-14 days before scheduled surgery
Plasma TNFalpha	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)	7-14 days after hospital discharge
Plasma TNFalpha	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)	7-14 days after completing the 8 week intervention period
Plasma TNFalpha	Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)	6 months after completing the intervention
Medication Monitoring Form	Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.	7-14 days before schedule surgery
Medication Monitoring Form	Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.	7-14 days after hospital discharge
Medication Monitoring Form	Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.	7-14 days after completing the 8 week intervention period
Medication Monitoring Form	Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.	6 months after completing the intervention
Treatment Expectation Questionnaire	This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).	Immediately prior to beginning the intervention
Treatment Satisfaction Questionnaire	Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.	Immediately following the completion of the intervention

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Sara Nowakowski, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Knee Arthroplasty; Hip Arthroplasty
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Arthritis; Joint Diseases; Rheumatic Diseases; Sleep Wake Disorders; Osteoarthritis; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Osteoarthritis, Knee; Sleep Initiation and Maintenance Disorders; Osteoarthritis, Hip; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: H - 45617 HealthyHab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No