Trial Outcomes & Findings for Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors (NCT NCT01254942)

NCT ID: NCT01254942

Last Updated: 2023-09-25

Results Overview

The primary outcome for this trial is the Short Physical Performance Battery (SPPB). The SPPB is composed of three separate tests that are timed and categorized depending on performance. The three domains evaluated in the SPPB are standing balance, gait speed, and sit to stand performance. The SPPB scores can range from 0-12, a higher score indicates better performance. The subscales are combined.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 12 months post-fracture
• Results posted on: 2023-09-25

Participant Flow

Participant milestones

Measure	Usual Care Usual care following hip fracture provided by the public health care system. this may include publicly funded home care services, rehab, and follow-up visits with doctors. Usual Care	Intervention Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program This is an interdisciplinary outpatient clinic within the public health care system. Participants were assessed by a geriatrician, physiotherapist, occupational therapist, and other health providers as needed. Management and sessions were determined by health providers and participants.
Overall Study STARTED	27	26
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors

Baseline characteristics by cohort

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Canada	27 participants n=5 Participants	26 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-fracture

The primary outcome for this trial is the Short Physical Performance Battery (SPPB). The SPPB is composed of three separate tests that are timed and categorized depending on performance. The three domains evaluated in the SPPB are standing balance, gait speed, and sit to stand performance.

The SPPB scores can range from 0-12, a higher score indicates better performance. The subscales are combined.

Outcome measures

Measure	Usual Care n=25 Participants Usual care following hip fracture Usual Care	Intervention n=24 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Short Physical Performance Battery	8.24 score on a scale Standard Deviation 2.44	9.08 score on a scale Standard Deviation 3.03

SECONDARY outcome

Timeframe: 12 months

difference between groups in minutes of sedentary behavior as captured by accelerometry

Outcome measures

Measure	Usual Care n=26 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Difference in Sedentary Behavior Minutes/Day	607 adjusted minutes sedentary behavior/day	603 adjusted minutes sedentary behavior/day

SECONDARY outcome

Timeframe: 12 months

number of self-reported falls over 12 months/group

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Falls	31 number of falls over 12 months/group	28 number of falls over 12 months/group

SECONDARY outcome

Timeframe: 12 months

self-reported quality of life measure, scores range from 0 to 1 (0 = no capability, 1 = full capability); the higher the score the better.

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Quality of Life (ICECAP-O)	0.81 units on a scale Standard Deviation 0.11	0.78 units on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 12 months

self-reported health related quality of life (Visual Analogue Scale, 0 to 100). The higher the score means a better outcome.

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Health Related Quality of Life (EQ5D-5L)	78.0 units on a scale Standard Deviation 15.5	77.2 units on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: 12 months

Self reported measure of lower extremity function. Scored 0 to 100. The higher the score the better.

Outcome measures

Measure	Usual Care n=25 Participants Usual care following hip fracture Usual Care	Intervention n=24 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Lower Extremity Measure	82.27 units on a scale Standard Deviation 14.55	88.72 units on a scale Standard Deviation 9.40

SECONDARY outcome

Timeframe: 12 months

measurement of walking speed over 3 or 4 meters

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Gait Speed (m/s)	0.91 m/s Standard Deviation 0.47	0.90 m/s Standard Deviation 0.31

SECONDARY outcome

Timeframe: 12 months

measurement of grip strength using a dynamometer

Outcome measures

Measure	Usual Care n=25 Participants Usual care following hip fracture Usual Care	Intervention n=23 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Grip Strength (Bilateral)	25.64 kg Standard Deviation 11.92	26.13 kg Standard Deviation 10.25

SECONDARY outcome

Timeframe: 12 months

measurement of leg strength using a hand-held dynamometer

Outcome measures

Measure	Usual Care n=25 Participants Usual care following hip fracture Usual Care	Intervention n=23 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Leg Strength (Fractured Leg)	19.63 kg Standard Deviation 7.55	18.87 kg Standard Deviation 8.13

SECONDARY outcome

Timeframe: baseline

Measure of global mobility, reported in s. Participant is asked to rise from a chair, walk 3 meters, turn and walk back to chair and sit down.

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Timed up and Go (TUG)	16.1 seconds Standard Deviation 10.4	16.1 seconds Standard Deviation 9.5

SECONDARY outcome

Timeframe: baseline

16 items, the lower the score the better, e.g., more falls efficacy (range from 7-28)

Outcome measures

Measure	Usual Care n=27 Participants Usual care following hip fracture Usual Care	Intervention n=26 Participants Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Falls Self-efficacy International (FES-I)	12.1 score on a scale Standard Deviation 5.7	9.8 score on a scale Standard Deviation 3.1

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=27 participants at risk Usual care following hip fracture Usual Care	Intervention n=26 participants at risk Follow-up Fracture Clinic B4 Clinic: Fracture Follow-Up Clinic plus Exercise Program
Musculoskeletal and connective tissue disorders Possible adverse event	0.00% 0/27	3.8% 1/26 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor MC Ashe

The University Of British Columbia

Phone: 604-675-2574

Email: maureen.ashe@ubc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place