Control4Life: A randomized controlled trial protocol examining the feasibility and efficacy of a combined pelvic health rehabilitation and exercise fitness program for individuals undergoing prostatectomy.

BACKGROUND: Urinary incontinence (UI), erectile dysfunction and cardiometabolic conditions are common after prostatectomy for prostate cancer (PCa). Although physical activity could improve overall survival and quality of survivorship, fear of UI can restrict participation in exercise. Individuals with PCa could benefit from therapeutic exercise programming to support continence recovery and cardiometabolic health. AIM: The main objective of this study is to determine the feasibility and the effects of a combined pelvic health rehabilitation and exercise fitness program on UI after prostatectomy. The combined exercise program will be delivered both in-person and virtually. METHODS: This study follows a modified Zelen, two-arm parallel randomized controlled trial design. A total of 106 individuals with PCa will be recruited before prostatectomy surgery. Participants will be randomized between two groups: one receiving usual care and one receiving a combined exercise fitness and intensive pelvic floor muscle training program. Exercise programming will begin 6-8 weeks after prostatectomy and will last 12 weeks. Outcomes include: the 24-h pad test (primary outcome for UI); physical fitness, metabolic indicators, and patient-reported outcomes on erectile function, self-efficacy, severity of cancer symptoms and quality of life. Important timepoints for assessments include before surgery (T0), after surgery (T1), after intervention (T3) and at one-year after surgery (T4). CONCLUSION: This study will inform the feasibility of offering comprehensive exercise programming that has the potential to positively impact urinary continence, erectile function and cardiometabolic health of individuals undergoing prostatectomy for prostate cancer. CLINICALTRIALS REGISTRATION NUMBER: NCT06072911.

Virtual or In-Person: A Mixed Methods Survey to Determine Exercise Programming Preferences during COVID-19.

A survey was conducted to identify barriers and facilitators to engaging in virtual and in-person cancer-specific exercise during COVID-19. A theory-informed, multi-method, cross-sectional survey was electronically distributed to 192 individuals with cancer investigating preferences towards exercise programming during COVID-19. Respondents had previously participated in an exercise program and comprised two groups: those who had experience with virtual exercise programming ('Virtual') and those who had only taken part in in-person exercise ('In-Person'). Quantitative data were summarized descriptively. Qualitative data were thematically categorized using framework analysis and findings were mapped to an implementation model. The survey completion response rate was 66% (N = 127). All respondents identified barriers to attending in-person exercise programming during COVID-19 with concerns over the increased risk of viral exposure. Virtual respondents (n = 39) reported: (1) feeling confident in engaging in virtual exercise; and (2) enhanced motivation, accessibility and effectiveness as facilitators to virtual exercise. In-Person respondents (n = 88) identified: (1) technology as a barrier to virtual exercise; and (2) low motivation, accessibility and exercise effectiveness as barriers towards virtual exercise. Sixty-six percent (n = 58) of In-Person respondents reported that technology support would increase their willingness to exercise virtually. With appropriately targeted support, perceived barriers to accessing virtual exercise-including motivation, accessibility and effectiveness-may become facilitators. The availability of technology support may increase the engagement of individuals with cancer towards virtual exercise programming.

Feasibility of Implementing Cancer-Specific Community-Based Exercise Programming: A Multi-Centre Randomized Trial.

BACKGROUND: There is growing recognition of the importance of reporting preliminary work on the feasibility of a trial. The present study aimed to assess the feasibility of (1) a proposed fitness testing battery, and (2) processes related to the implementation of cancer-specific exercise programming in a community setting. METHODS/DESIGN: A randomized controlled implementation feasibility trial was performed in advance of a large-scale implementation study. Eligible participants within 18 months of a cancer diagnosis were randomized to immediate or delayed community-based exercise at YMCA locations in Calgary and Edmonton, Canada for an 8-week period. The primary outcome for the trial was the feasibility of the physical fitness testing battery, defined as a 70% or greater completion rate across the 24-week study period. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to evaluate processes related to implementation of the exercise program across the two sites. RESULTS: Eighty participants were recruited, 73 (91%) completed the 8-week trial, and 68 (85%) completed the 16- and 24-week follow-ups. Sixty participants (75%) completed the full physical fitness test battery at each time point, and 59 (74%) completed the patient-reported outcome measures. Statistically significant between-group differences were found in favor of the exercise group for functional aerobic capacity, upper and lower extremity strength, and symptoms. Differences were found between the sites, however, in completion rates and processes related to program implementation. DISCUSSION: Findings suggest the need for minor adaptations to the physical fitness battery and outcome measures to better fit the community context. While findings support feasibility, context-specific challenges related to implementation processes were identified.

Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease.

Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary - virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes - protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.

Therapeutic Ultrasound for Chemotherapy-Related Pain and Sensory Disturbance in the Hands and Feet in Patients With Colorectal Cancer: A Pilot Randomized Controlled Trial.

CONTEXT: This proof-of-concept trial was undertaken as a first step in exploring the clinical benefit of therapeutic ultrasound for pain and sensory disturbance in patients with colorectal cancer. OBJECTIVES: The aim of this study was to determine the feasibility and preliminary efficacy of adding therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care) for patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet. METHODS: Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician-rated grade 1, 2, or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial. Patients were randomized to either 10 sessions of ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm2, and frequency of 3 MHz for 5 minutes) plus standard care (n = 16) or to standard care alone (n = 15). The feasibility of therapeutic ultrasound was determined by the recruitment rate, participants' adherence to the intervention, and the study completion rates. Assessments of pain, sensory disturbance, sensation, and balance were conducted at baseline, two and six weeks. RESULTS: We achieved a recruitment rate of 84%, an adherence rate of 100% to the intervention, and a completion rate of 100%. Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (P = 0.003) at two weeks; however, no significance difference between the groups was found at the six-week follow-up. CONCLUSIONS: The findings of this proof-of-concept study support the feasibility of the therapeutic ultrasound in addition to standard care as an intervention for colorectal cancer patients with oxaliplatin-related pain and sensory disturbance in the hands and feet. The findings warrant a large-scale placebo-controlled trial.

A Practical Approach to Using Integrated Knowledge Translation to Inform a Community-Based Exercise Study.

BACKGROUND: Our aim was to understand cancer survivor needs prior to, and following the Alberta Cancer Exercise (ACE) pilot randomized trial as a means to inform implementation of a province-wide cancer-specific, community-based exercise program. METHODS: Questionnaires and semi-structured stakeholder engagement sessions were conducted with cancer survivors to explore preferences, barriers and facilitators/benefits at two timepoints: (1) pre-ACE: prior to initiation of the ACE pilot trial (n = 13 survivors and n = 5 caregivers); and (2) post-ACE: following participation in the ACE pilot trial (n = 20 survivors). Descriptive statistics were used to summarize quantitative data from questionnaires. Stakeholder engagement data were analyzed using a framework analysis approach. Emergent themes were then mapped to actionable outcomes. RESULTS: Pre-ACE, survivors indicated a preference for exercise programs that were (1) supervised by exercise specialists knowledgeable about cancer, (2) included support from other health care providers, (3) were held in community locations that were easily accessible. Post-ACE, participants identified (1) a lack of exercise counseling from health care providers, (2) the need for earlier introduction of exercise in the care pathway, and (3) supported referral to exercise programming. CONCLUSIONS: An integrated knowledge translation approach identified actionable outcomes to address survivor needs related to exercise in clinical cancer and community-based contexts.

The Interdisciplinary Rehabilitation Care Team and the Role of Physical Therapy in Survivor Exercise.

BACKGROUND: Rehabilitation professionals offer expertise in functional assessment, treatment of impairments and functional limitations, and disability prevention. To optimize recovery, and often prior to participating in community-based exercise programming, survivors may need rehabilitation services from a range of healthcare professionals, including physiatrists, nurses, nutritionists, psychologists, and speech, occupational, and physical therapists. OBJECTIVES: Survivors with physical impairments and functional limitations may benefit from interdisciplinary rehabilitation and physical therapy, including tailored therapeutic exercise interventions. METHODS: A literature review was conducted using the key words cancer survivor, cancer rehabilitation, impairment, fatigue, lymphedema, chemotherapy-induced peripheral neuropathy, and exercise. MEDLINE®, EMBASE, Cochrane Database of Systematic Reviews, and CINAHL® databases were searched. FINDINGS: Nurses play a critical role in identifying survivors whose function or fitness is compromised to the point where participation in community-based exercise programming would be inappropriate or unsafe. The interdisciplinary rehabilitation care team can help facilitate the survivor's transition to community-based exercise programming.