Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

Physical Inactivity Clinical Trial

Official title:

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285748
• Other study ID #: R01AG069349
• Secondary ID: F32AG074680
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2022
• Est. completion date: May 2026

Study information

• Verified date: July 2022
• Source: Brown University
• Contact: Lauren C Bohlen, Ph.D.
• Phone: 401-863-6559
• Email: lauren_bohlen[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion criteria:

• ages 50-64

• BMI 25-40

• Sedentary or low-active, defined as participating in < 60 min/week of structured exercise

• Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

Exclusion criteria:

• Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):

• Past 3-month overnight hospitalization

• Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm

• Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury

• Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity

• Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly

• Past 6-month seizure

• Past 6-month overnight hospitalization due to respiratory disease

• Past 6-month lightheadedness, vertigo, dizziness, or fainting

• Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months

• Takes insulin and/or medication that affects the secretion of insulin

• Exercise-induced asthma that prevents brisk walking

• Takes anticonvulsant medication or medication to treat/control seizures

• Diagnosed with cystic fibrosis

• Bone or joint problems that make you unable to walk for at least 30 minutes

• Physician has said not to exercise because of bone or joint problems

• Physician has said a hip or knee replacement will be needed in the next 12 months

• Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes

• Currently taking or planning on taking medications that affect HR, such as beta or calcium channel blockers or digoxin, as HR will be used to determine the moderate intensity range for participants assigned to that condition

• Past 12-month overnight psychiatric hospitalization

• Currently pregnant or planning to become pregnant in the next year

• Currently participating in any exercise or weight-loss research studies

• Household member is participating in this study

• Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box

• Unable to receive materials in the mail at residential mailing address

• Does not plan to live in Rhode Island for the next 12 months

• Unable to speak, read, and/or write fluently in English

• Smokers will be eligible, but smoking status will be included as a covariate in analyses

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Self-Paced Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.
• Prescribed Moderate Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opportunity Questionnaire	Measures a person's opportunity to do regular aerobic physical activity	Measured at baseline, and months 3, 6, 9, and 12.
Other	Capability Questionnaire	Measures a person's physical and psychological capability to do regular aerobic physical activity	Measured at baseline, and months 3, 6, 9, and 12.
Other	Exercise Motivation Questionnaire	Measures a person's motivation on the days they have made a plan to exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Habit of Physical Activity Questionnaire	Measures a person's habits regarding exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Physical Activity Identity Questionnaire	Measures a person's personal beliefs regarding exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Outcome Expectations for Physical Activity Questionnaire	Measures a person's beliefs about the consequences of exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Attitude towards Physical Activity - Affective Attitude Questionnaire	Measures a person's beliefs about exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Attitude towards Physical Activity - Instrumental Attitude Questionnaire	Measures a person's beliefs about exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)	Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment	Measured at baseline, and months 3, 6, 9, and 12.
Other	Intention Questionnaire	Measures a person's intention to exercise	Measured at baseline, and months 3, 6, 9, and 12.
Other	Chronic Pain Screening Questionnaire	Measures how much chronic pain a person had in the past 6 months	Measured at baseline, and months 3, 6, 9, and 12.
Other	Pain Medication Use Questionnaire	Measures the medications a person is taking for chronic pain	Measured at baseline, and months 3, 6, 9, and 12.
Other	12 Item Short Form (SF-12) Health Survey	Measures a person's views about their health	Measured at baseline, and months 3, 6, 9, and 12.
Other	Quality of Life Questionnaire	Measures a person's views about their quality of life and health	Measured at baseline, and months 3, 6, 9, and 12.
Other	Activity Tracker Use Questionnaire	Measures of use of physical activity devices, memberships, and equipment	Measured at baseline, and months 3, 6, 9, and 12.
Other	EMA: Affective response to PA	Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.	Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
Other	EMA: Perceived autonomy	Assesses participant's perceived autonomy over exercise behavior.	Measured weekly from date of randomization until the end of the study at week 52
Other	EMA: Perceived exertion	Assesses participant's perceived exertion during PA.	Measured daily from date of randomization until the end of the study at week 52
Other	EMA: Behavioral intention	Assesses degree to which participant intends to engage in PA.	Measured daily from date of randomization until the end of the study at week 52
Other	EMA: PA setting	Assessed the physical and social setting in which a participant engages in physical activity.	Measured daily from date of randomization until the end of the study at week 52
Other	EMA: Anticipated, remembered, and incidental affect	Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.	Measured daily from date of randomization until the end of the study at week 52
Other	EMA: Self-Efficacy for Physical Activity	Measures beliefs about capabilities to be physically active	Measured daily from date of randomization until the end of the study at week 52
Other	EMA: Social Support for Exercise	Measures a person's social support available to help them exercise	Measured daily from date of randomization until the end of the study at week 52
Primary	Change in total volume of structured PA	Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph [model wGT3x-BT]) worn during one-week periods.	Measured at baseline, and months 3, 6, 9, and 12.
Primary	Minutes per week of PA	Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.	Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Secondary	Changes in Body Weight	Assessment of self-reported body weight by study-provided scales	Measured at baseline, and months 3, 6, 9, and 12.