Trial Outcomes & Findings for STepped Exercise Program for Knee OsteoArthritis (NCT NCT02653768)

Last Updated: 2024-02-14

Results Overview

This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total scale range is 0-96, and higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

345 participants

Primary outcome timeframe

Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.

Results posted on

2024-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	STEP-KOA This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
3-Month Follow-Up STARTED	230	115
3-Month Follow-Up COMPLETED	164	100
3-Month Follow-Up NOT COMPLETED	66	15
6-Month Follow-Up STARTED	209	113
6-Month Follow-Up COMPLETED	164	100
6-Month Follow-Up NOT COMPLETED	45	13
9-Month Follow-Up (Primary) STARTED	196	111
9-Month Follow-Up (Primary) COMPLETED	163	95
9-Month Follow-Up (Primary) NOT COMPLETED	33	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STepped Exercise Program for Knee OsteoArthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STEP-KOA n=230 Participants This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 Participants The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.	Total n=345 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 9.9 • n=99 Participants	60.2 years STANDARD_DEVIATION 11.1 • n=107 Participants	60.0 years STANDARD_DEVIATION 10.3 • n=206 Participants
Sex: Female, Male Female	30 Participants n=99 Participants	15 Participants n=107 Participants	45 Participants n=206 Participants
Sex: Female, Male Male	200 Participants n=99 Participants	100 Participants n=107 Participants	300 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	224 Participants n=99 Participants	109 Participants n=107 Participants	333 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	142 Participants n=99 Participants	66 Participants n=107 Participants	208 Participants n=206 Participants
Race (NIH/OMB) White	72 Participants n=99 Participants	39 Participants n=107 Participants	111 Participants n=206 Participants
Race (NIH/OMB) More than one race	11 Participants n=99 Participants	6 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants

PRIMARY outcome

Timeframe: Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.

Population: Intent to treat. Only the STEP-KOA group was assessed at 15 months. This was planned because the AE group could start receiving treatment after 9 months.

Outcome measures

Outcome measures
Measure	STEP-KOA n=230 Participants This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 Participants The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Mean Change Scores from Baseline to 3-months	-4.85 units on a scale Standard Error 1.00	0.26 units on a scale Standard Error 1.27
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Mean changes scores from baseline to 6-months	-3.97 units on a scale Standard Error 1.20	-2.53 units on a scale Standard Error 1.54
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Mean change scores from baseline to 9-months	-5.46 units on a scale Standard Error 1.15	1.38 units on a scale Standard Error 1.49
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Mean change scores from 9 months to 15-months	3.02 units on a scale Standard Error 1.38	—

SECONDARY outcome

Timeframe: Change from baseline to 9-month follow-up

Population: Intent to treat

The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).

Outcome measures

Outcome measures
Measure	STEP-KOA n=230 Participants This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 Participants The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
30-second Chair Stand	-0.23 Number of chair stands Standard Error 0.29	-0.59 Number of chair stands Standard Error 0.37

SECONDARY outcome

Timeframe: Change from baseline to 9-month follow-up

Population: Intent to treat

The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance. Lower scores mean better outcome (e.g. faster walking speed).

Outcome measures

Outcome measures
Measure	STEP-KOA n=230 Participants This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 Participants The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
40m Fast-paced Walk	-0.72 seconds Standard Error 1.26	1.61 seconds Standard Error 1.57

Adverse Events

STEP-KOA

Serious events: 23 serious events

Other events: 3 other events

Deaths: 1 deaths

Arthritis Education (AE)

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	STEP-KOA n=230 participants at risk This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 participants at risk The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
Injury, poisoning and procedural complications Fall with minor injuries	0.87% 2/230 • Number of events 2 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Musculoskeletal and connective tissue disorders Increased hip pain	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.

Additional Information

Kelli Allen, Associate Director

Center to Accelerate Discovery and Practice Transformation, Durham VA

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	STEP-KOA n=230 participants at risk This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit	Arthritis Education (AE) n=115 participants at risk The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines.
Vascular disorders Hospitalization due bypass of peripheral artery	0.43% 1/230 • Number of events 2 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Blood and lymphatic system disorders Hospitalization for lymphatic leak following peripheral artery bypass	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Hospitzalization for cardiac stents	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Fall leading to injury (not study related)	0.87% 2/230 • Number of events 2 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Blood and lymphatic system disorders Blood clot in leg	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Heart block	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Surgical and medical procedures Hernia surgery	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Nervous system disorders Stroke	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Hospitalization following car accident	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Emergency Department Visit due to twisted ankle	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Emergncy room visit due to swollen legs and chest pain	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Adverse drug reaction	0.87% 2/230 • Number of events 2 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Persistent soreness following car accident	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Infections and infestations Hospitalziation due to flu symptoms	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Infections and infestations Emergency room visit due to a cold	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Infections and infestations Hospitalization due to infection after liver biopsy	0.43% 1/230 • Number of events 2 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer diagnosis	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Emergency department visit for knee pain after falling out of bed	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Torn ligament in knee	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Nervous system disorders Mini-strokes	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Injury, poisoning and procedural complications Emergency department visit for heat stroke	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Hospitalization for cardiac catheterization and complidcations	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Psychiatric disorders Hospitalization due to depression	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Hospital visit due to high blood pressure	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Hospitalization due to aneurysm	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Nervous system disorders Hospitalization due to vertigo	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Cardiac disorders Emergency department visit due to atrial fibrillation	0.43% 1/230 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.00% 0/115 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Surgical and medical procedures Knee replacement surgery	0.00% 0/230 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.	0.87% 1/115 • Number of events 1 • 15 months for each participant Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.